[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58675-58681]
[FR Doc No: 2021-23075]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1037]

Fresenius USA, Inc., et al.; Withdrawal of Approval of 216
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 216 abbreviated new drug applications (ANDAs)
from multiple holders of those ANDAs. The basis for the withdrawal is
that these ANDA holders have repeatedly failed to submit required
annual reports for those ANDAs.

DATES: Approval is withdrawn as of November 22, 2021.

FOR FURTHER INFORMATION CONTACT: James Hanratty, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-
402-4718, James.Hanr[email protected].

SUPPLEMENTARY INFORMATION: The holders of an approved application to
market a new drug for human use are required to submit annual reports
to FDA concerning their approved application in accordance with
Sec. Sec.  314.81 and 314.98 (21 CFR 314.81 and 314.98). In the Federal
Register of January 9, 2020 (85 FR 1160), FDA published a notice
offering an opportunity for a hearing (NOOH) on a proposal to withdraw
approval of 249 ANDAs because the holders of those ANDAs had repeatedly
failed to submit the required annual reports for those ANDAs
(``Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249
Abbreviated New Drug Applications; Opportunity for a Hearing'').\1\ The
holder of ANDA 085882, ANDA 086262, and ANDA 0866263 responded to the
NOOH and requested a hearing. The remaining holders of those ANDAs did
not respond to the NOOH. Failure to file a written notice of
participation and request for hearing as required by Sec.  314.200
constitutes an election by those holders of the ANDAs not to make use
of the opportunity for a hearing concerning the proposal to withdraw
approval of their ANDAs and a waiver of any contentions concerning the
legal status of the drug products. Therefore, FDA is withdrawing
approval of the 216 applications listed in table 1.
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    \1\ 85 FR 1160, published on January 9, 2020, incorrectly listed
249 as the number of the ANDAs FDA proposed to withdrawal. 85 FR
1160 listed 248 ANDAs in the table included in the notice.
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I. Annual Reports Submitted

    In response to the NOOH, one firm requested a hearing and had
previously submitted an annual report for each of its three ANDAs.
Therefore, FDA rescinds its proposal to withdraw approval of the
following three ANDAs:

Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920:

 ANDA 085882, DUVOID (bethanechol chloride) Tablets, 50
milligrams (mg)
 ANDA 086262, DUVOID (bethanechol chloride) Tablets, 10 mg
 ANDA 086263, DUVOID (bethanechol chloride) Tablets, 25 mg

    Another three firms notified the Agency that they had submitted an
annual report for each of its ANDAs listed in the NOOH. Therefore, FDA
rescinds its proposal to withdraw approval of the following eight
ANDAs:
    Jerome Stevens Pharmaceuticals Inc., 60 DaVinci Dr., Bohemia, NY
11716:

 ANDA 062869, CEPHALEXIN Capsules USP, EQ 500 mg base
 ANDA 062870, CEPHALEXIN Capsules USP, EQ 250 mg base
 ANDA 074988, ASPIRIN, CAFFEINE, AND ORPHENADRINE CITRATE
Tablets, 385 mg/30 mg/25 mg, and 770 mg/60 mg/50 mg
 ANDA 081145, ASPIRIN AND METHOCARBAMOL Tablets, 325 mg/400 mg

    MIPS Cyclotron and Radiochemistry Facility, 1201 Welch Rd., Rm.
PS049, Stanford, CA 94305:

 ANDA 204472, FLUDEOXYGLUCOSE F-18 Injection USP, 20-300
millicuries (mCi)/milliliters (mL)
 ANDA 204517, SODIUM FLUORIDE F-18 Injection, 10-200 mCi/mL
 ANDA 204535, AMMONIA N-13 Injection USP, 3.75-37.5 mCi/mL

    Milex Products, Inc., 5915 Northwest Hwy., Chicago, IL 60631:

 ANDA 072196, MILOPHENE (clomiphene citrate) Tablets, 50 mg

II. Previously Consolidated Application

    Sandoz, Inc., 4700 Eon Dr., Wilson, NC 27893, notified the Agency
that ANDA 084631, QUINIDINE SULFATE Tablets USP, 200 mg, had previously
been consolidated with ANDA 088072. Therefore, FDA rescinds its
proposal to withdraw approval of this ANDA.

III. Previously Transferred Application

    Pfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd St.,
New York, NY 10017, notified the Agency that ANDA 060074, PENICILLIN G
POTASSIUM for Injection, 20,000,000 units/vial, had previously been
transferred to Cultor Food Science, Inc. Therefore, FDA rescinds its
proposal to withdraw approval of this ANDA.

IV. Requests To Withdraw Approval

    In response to the NOOH, 13 firms notified the Agency that they no
longer market 15 of the ANDAs listed in the NOOH and had previously
submitted written requests for withdrawal for the following ANDAs:
    1. Parkedale Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620,
notified the Agency that they no longer market the product for ANDA
060521, HUMATIN (paromomycin sulfate) Capsules USP, Equivalent to (EQ)
250 mg base. On May 12, 2021 (86 FR 26058), the Agency withdrew
approval of this ANDA at the written request of the applicant.
    2. Roerig Division of Pfizer Inc., 235 East 42nd St., New York, NY
10017, notified the Agency that they no longer market the product for
ANDA 060709, OLEANDOMYCIN Injection. On July 21, 2020 (85 FR 44096),
the Agency withdrew approval of this ANDA under the written request of
the applicant.
    3. Pharmacia and Upjohn Co., 7171 Portage Rd., Kalamazoo, MI 49001,
notified the Agency that they no longer market the product for ANDA
061034, LINCOMYCIN HYDROCHLORIDE (HCl) Powder. On May 12, 2021, the
Agency withdrew approval of this ANDA under the written request of the
applicant.
    4. Lederle Laboratories, Division of American Cyanamid Co., 401
North Middletown Rd., Pearl River, NY 10965, notified the Agency that
they no longer market the product for ANDA 061064, NYSTATIN Ointment.
On May 12, 2021, the Agency withdrew approval of this ANDA under the
written request of the applicant.
    5. Pfizer Laboratories, Division of Pfizer Inc., 235 East 42nd St.,
New York, NY 10017, notified the Agency that they no longer market the
product for ANDA 061087, BENZOCAINE, OXYTETRACYCLINE HCl, and POLYMYXIN
B SULFATE OTIC Solution. On July 21, 2020, the Agency withdrew approval
of this ANDA under the written request of the applicant.
    6. Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950,
notified the Agency that they no longer market the product for ANDA
061652, OXYTETRACYCLINE Capsules. On May 12, 2021, the Agency withdrew
approval of this ANDA under the written request of the applicant.
    7. AH Robins Co., 1211 Sherwood Ave., Richmond, VA 23220, notified
the Agency that they no longer market the product for ANDA 061701,
TETRACYCLINE Syrup, 125 mg/5 mL. On May 12, 2021, the Agency withdrew
approval of this ANDA under the written request of the applicant.
    8. Warner Chilcott, Division of Warner Lambert-Pfizer, Inc., 235
East 42nd St., New York, NY 10017, notified the Agency that they no
longer market the products for ANDA 061725, TETRACYCLINE HCl Capsules,
250 mg and 500 mg, and ANDA 062175, TETRACYCLINE HCl Capsules, 250 mg.
On July 21, 2020, the Agency withdrew approval of these ANDAs under the
written request of the applicant.
    9. Lederle Laboratories, Division of American Cyanamid Co., 1
Cyanamid Plaza, Wayne, NJ 07470, notified the Agency that they no
longer market the products for ANDA 061943, CHLORAMPHENICOL Ophthalmic
Solution, 0.5 percent; ANDA 062215, OXYTETRACYCLINE HCl Capsules. On
July 21, 2020, the Agency withdrew approval of these ANDAs under the
written request of the applicant.
    10. Warner-Lambert Co. notified the Agency that they no longer
market the product for ANDA 062032, EYPAR (erythromycin stearate)
Tablets, EQ 250 mg base and EQ 500 mg base. On May 12, 2021, the Agency
withdrew approval of this ANDA under the written request of the
applicant.
    11. Becton Dickinson and Co., Surgical System, 9450 South State
St., Sandy, UT 84070, notified the Agency that they no longer market
the product for ANDA 073416, E-Z SCRUB (chlorhexidine gluconate)
Topical Sponge, 4 percent. On January 8, 2020 (85 FR 909), the Agency
withdrew approval of this ANDA under the written request of the
applicant.
    12. Lederle Laboratories, Division of American Cyanamid Co., Pearl
River, NY 10965-1215, notified the Agency that they no longer market
the products for ANDA 083001, TRIAMCINOLONE ACETONIDE Aerosol Foam
Emulsion. On May 12, 2021, the Agency withdrew approval of this ANDA
under the written request of the applicant.
    13. Lederle Laboratories, Division of American Cyanamid Co., Pearl
River, NY 10965-1215, notified the Agency that they no longer market
the product for ANDA 084803, CHLORPROMAZINE HCl Tablets, 10 mg. On May
12, 2021, the Agency withdrew approval of this ANDA under the written
request of the applicant.

V. Previously Withdrawn Applications

    In the Federal Register of September 25, 2020 (85 FR 60474), FDA
published a separate notice offering an opportunity for a hearing
(NOOH) on a proposal to withdraw approval of ANDAs because the holders
of those ANDAs had repeatedly failed to submit the required annual
reports and have failed to satisfy the requirement to have an approved
risk evaluation and mitigation strategy for the following ANDAs:
    1. Everylife, 2021 15th Avenue West, Seattle, WA 98119: ANDA
085217, ACETAMINOPHEN and CODEINE PHOSPHATE Tablet, 325 mg/30 mg.
    2. Scherer Laboratories, Inc., 2301 Ohio Dr., Suite 234, Plano, TX
75093: ANDA 085638, ACETAMINOPHEN, ASPIRIN, and CODEINE, 150 mg/180 mg/
60 mg; ANDA 085639, ACETAMINOPHEN, ASPIRIN, and CODEINE PHOSPHATE
Capsule, 150 mg/180 mg/30 mg; ANDA 085640, ACETAMINOPHEN, ASPIRIN, and
CODEINE PHOSPHATE Capsule, 150 mg/180 mg/15 mg.
    The holders of the applications did not respond to the Federal
Register NOOH of September 25, 2020. Failure to submit a written notice
of participation and request for hearing as required by Sec.  314.200
constitutes an election by those holders not to make use of the
opportunity for a hearing concerning the proposal to withdraw approval
of their ANDAs and a waiver of any contentions concerning the legal
status of the drug products. On April 9, 2021 (86 FR 18542), the Agency
withdrew approval of these ANDAs.

VI. No Response to NOOH Received

    The holders of the other 216 applications did not respond to the
NOOH. Failure to submit a written notice of participation and request
for hearing as required by Sec.  314.200 constitutes an election by
those holders not to make use of the opportunity for a hearing
concerning the proposal to withdraw approval of their ANDAs and a
waiver of any contentions concerning the legal status of the drug
products. Therefore, the Director, Center for Drug Evaluation and
Research, is withdrawing approval of the 216 applications listed in
table 1.

    Table 1--Approved ANDAs for Which Required Reports Have Not Been
                                Submitted
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      Application No.                Drug                Applicant
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ANDA 020374...............  Inpersol-LC/LM with    Fresenius USA, Inc.,
                             Dextrose 1.5%          2637 Shadelands Dr.,
                             (calcium chloride,     Walnut Creek, CA
                             dextrose, magnesium    94598.
                             chloride, sodium
                             chloride, sodium
                             lactate)
                             Intraperitoneal
                             Solution, 18.4 mg/
                             100 mL; 1.5 grams
                             (g)/100 mL; 5.08 mg/
                             100 mL; 538 mg/100
                             mL; 448 mg/100 mL.
                            Inpersol-LC/LM with
                             Dextrose 2.5%
                             (calcium chloride,
                             dextrose, magnesium
                             chloride, sodium
                             chloride, sodium
                             lactate)
                             Intraperitoneal
                             Solution, 18.4 mg/
                             100 mL; 2.5 g/100
                             mL; 5.08 mg/100 mL;
                             538 mg/100 mL; 448
                             mg/100 mL.
                            Inpersol-LC/LM with
                             Dextrose 3.5%
                             (calcium chloride,
                             dextrose, magnesium
                             chloride, sodium
                             chloride, sodium
                             lactate)
                             Intraperitoneal
                             Solution, 18.4 mg/
                             100 mL; 3.5 g/100
                             mL; 5.08 mg/100 mL;
                             538 mg/100 mL; 448
                             mg/100 mL.
                            Inpersol-LC/LM with
                             Dextrose 4.25%
                             (calcium chloride,
                             dextrose, magnesium
                             chloride, sodium
                             chloride, sodium
                             lactate)
                             Intraperitoneal
                             Solution, 18.4 mg/
                             100 mL; 4.25 g/100
                             mL; 5.08 mg/100 mL;
                             538 mg/100 mL; 448
                             mg/100 mL.
ANDA 040057...............  Epinephrine and        Eastman Kodak Co.,
                             Lidocaine              343 State St.,
                             Hydrochloride (HCl)    Rochester, NY 14650.
                             Injection, 0.01 mg/
                             mL; 2% and 0.02 mg/
                             mL; 2%.
ANDA 040168...............  Hydrocortisone and     Wockhardt EU
                             Acetic Acid Otic       Operations (Swiss)
                             Solution USP, 1%/2%.   AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc., 6451 West Main
                                                    St., Morton Grove,
                                                    IL 60053.
ANDA 040192...............  Prednisolone Syrup,    WE Pharmaceuticals,
                             15 mg/5 mL.            Inc., 1142 D St.,
                                                    P.O. Box 1142,
                                                    Ramona, CA 92065.
ANDA 060131...............  Tetracycline HCl       Leiner Health
                             Capsules.              Products, Inc., 901
                                                    East 233rd St.,
                                                    Carson, CA 90745.
ANDA 060461...............  Neomycin Sulfate       Ambix Laboratories,
                             Ointment; Neomycin     Division of Organics
                             Sulfate and            Corp. of America,
                             Hydrocortisone         210 Orchard St.,
                             Acetate Ointment.      East Rutherford, NJ
                                                    07073.
ANDA 060602...............  Penicillin G           John D. Copanos and
                             Potassium Powder.      Co., Inc., 6110
                                                    Robinwood Rd.,
                                                    Baltimore, MD 21225.
ANDA 060627...............  Tribiotic (polymyxin   Ambix Laboratories,
                             B sulfate,             Division of Organics
                             bacitracin, and        Corp. of America.
                             neomycin sulfate)
                             Ointment, 5000 units/
                             400 units/5 mg.
ANDA 060724...............  Pyocidin-HC (neomycin  Kasco-EFCO
                             sulfate, polymyxin B   Laboratories, Inc.,
                             sulfate, and           Cantiague Rock Rd.,
                             hydrocortisone) Otic   Hicksville, NY
                             Solution.              11802.
ANDA 060769...............  Tetracycline Syrup...  West-Ward
                                                    Pharmaceutical
                                                    Corp., 465
                                                    Industrial Way West,
                                                    Eatontown, NJ 07724.
ANDA 060773...............  Tetracycline Syrup...  Leiner Health
                                                    Products, Inc.
ANDA 060870...............  Oxytetracycline        Proter S.p.A., c/o
                             Injection.             Richmar
                                                    International, Inc.,
                                                    1706 Birch Rd.,
                                                    McLean, VA 22101.
ANDA 061154...............  Hydrocortisone         Ambix Laboratories,
                             Acetate and Neomycin   Division of Organics
                             Sulfate Ointment.      Corp. of America.
ANDA 061209...............  Bacitracin Ointment     Do.
                             USP, 500 units/g.
ANDA 061228...............  Griseofulvin Capsules  Owen Laboratories,
                                                    Division of Alcon
                                                    Laboratories, 3737
                                                    Beltline Rd.,
                                                    Dallas, TX 75234.
ANDA 061483...............  Penicillin G           Leiner Health
                             Potassium Tablets.     Products, Inc.
ANDA 061518...............  Bacitracin Zinc        Rexall Drug Co., 135
                             Ointment.              Chesterfield
                                                    Industrial Blvd.,
                                                    Chesterfield, MO
                                                    63017.
ANDA 061519...............  Bacitracin Zinc and     Do.
                             Neomycin Sulfate
                             Ointment.
ANDA 061520...............  Bacitracin Zinc and     Do.
                             Neomycin Sulfate/
                             Polymyxin B Sulfate
                             Ointment.
ANDA 061521...............  Bacitracin Zinc,        Do.
                             Benzocaine, and
                             Neomycin Sulfate/
                             Polymyxin B Sulfate
                             Ointment.
ANDA 061528...............  Penicillin V           American Antibiotics,
                             Potassium Tablets      Inc., 6110 Robinwood
                             USP, EQ 250 mg base    Rd., Baltimore, MD
                             and EQ 500 mg base.    21225.
ANDA 061529...............  Penicillin V            Do.
                             Potassium for Oral
                             Solution USP, EQ 125
                             mg base/5 mL and EQ
                             250 mg base/5 mL.
ANDA 061532...............  Ampicillin Trihydrate  Leiner Health
                             Capsules.              Products, Inc.
ANDA 061601...............  Ampicillin for Oral    American Antibiotics,
                             Suspension USP, EQ     Inc.
                             125 mg base/5 mL and
                             EQ 250 mg base/5 mL.
ANDA 061602...............  Ampicillin Capsules     Do.
                             USP, EQ 250 mg base
                             and EQ 500 mg base.
ANDA 061632...............  Ampicillin Trihydrate  Chromalloy
                             Capsules, 250 mg.      Pharmaceuticals,
                                                    Inc., 5353 Grosvenor
                                                    Blvd., Los Angeles,
                                                    CA 90066.
ANDA 061674...............  Penicillin V           Leiner Health
                             Potassium Tablets.     Products, Inc.
ANDA 061697...............  Griseofulvin Capsules  Watson Laboratories,
                                                    Inc., 311 Bonnie
                                                    Cir., Corona, CA
                                                    92880.
ANDA 061699...............  Bacitracin Powder for  Apothekernes
                             Rx Compounding,        Laboratorium A.S., c/
                             5,000,000 units/       o AL Laboratories,
                             bottle.                Inc., 1 Executive
                                                    Dr., Fort Lee, NJ
                                                    07024.
ANDA 061833...............  Oxytetracycline HCl    Pliva, c/o Transtrade
                             Capsules, 250 mg.      USA, Ltd., 515
                                                    Madison Ave., 4th
                                                    Floor East, New
                                                    York, NY 10022.
ANDA 061847...............  Bleomycin Sulfate      Takasaki Plant,
                             Injection.             Nippon Kayaku Co.,
                                                    Ltd., 500 5th Ave.,
                                                    Suite 1726, New
                                                    York, NY 10110.

ANDA 061857...............  Penicillamine Powder.  Chemiewerk Homberg, c/
                                                    o Wallace
                                                    Laboratories,
                                                    Cranbury, NJ 08512.
ANDA 061903...............  Bacitracin Zinc and    Ambix Laboratories,
                             Polymyxin B Sulfate    Division of Organics
                             Ointment.              Corp. of America.
ANDA 062085...............  Tetracycline HCl       MM Mast and Co., 4152
                             Capsules, 250 mg.      Ruple Rd.,
                                                    Cleveland, OH 44121.
ANDA 062205...............  Cefaclor Capsules      Ceph International
                             USP, EQ 250 mg base    Corp. c/o Mova
                             and EQ 500 mg base.    Pharmaceutical
                                                    Corp., State Rd. #1,
                                                    Jose Garrido St.,
                                                    Cagus, PR 00725.
ANDA 062340...............  Gentamicin Sulfate     Pharmaceutical
                             Injection.             Specialist
                                                    Association, 9852
                                                    Cowden St.,
                                                    Philadelphia, PA
                                                    19115.
ANDA 062467...............  E-Solve 2              Syosset Laboratories,
                             (erythromycin)         Inc., 150 Eileen
                             Lotion, 2%.            Way, Syosset, NY
                                                    11791.
ANDA 062758...............  Eryzole (erythromycin  Alra Laboratories,
                             ethylsuccinate and     Inc., 3850 Clearview
                             sulfisoxazole          Ct., Gurnee, IL
                             acetyl) Granules, EQ   60031.
                             200 mg base/5 mL; EQ
                             600 mg base/5 mL.
ANDA 062944...............  Clindamycin Phosphate  BOCA Pharmacal, LLC.,
                             Topical Solution       3550 North West
                             USP, EQ 1% base.       126th Ave., Coral
                                                    Springs, FL 33065.
ANDA 070104...............  Chlorhexidine          Matrix Medical Corp.,
                             Gluconate Topical      1825 South 3730
                             Solution, 4%.          West, Salt Lake
                                                    City, UT 84104.
ANDA 071054...............  Constilac (lactulose)  Alra Laboratories,
                             Solution, 10 g/15 mL.  Inc.
ANDA 071057...............  Ibu-tab 200             Do.
                             (ibuprofen) Tablets,
                             200 mg.
ANDA 071058...............  Ibu-tab (ibuprofen)     Do.
                             Tablets, 400 mg.
ANDA 071059...............  Ibu-tab (ibuprofen)     Do.
                             Tablets, 600 mg.
ANDA 071104...............  Leucovorin Calcium     Xanodyne Pharmacal,
                             Tablets, EQ 15 mg      Inc., 7310 Turfway
                             base.                  Rd., Suite 490,
                                                    Florence, KY 41042.
ANDA 071139...............  Trazodone HCl          American
                             Tablets, 50 mg.        Therapeutics, Inc.,
                                                    89 Carlough Rd.,
                                                    Bohemia, NY 11716.
ANDA 071140...............  Trazodone HCl           Do.
                             Tablets, 100 mg.
ANDA 071331...............  Cholac (lactulose)     Alra Laboratories,
                             Solution, 10 g/15 mL.  Inc.
ANDA 071362...............  Meclofenamate Sodium   American
                             Capsules USP, 50 mg.   Therapeutics, Inc.
ANDA 071363...............  Meclofenamate Sodium    Do.
                             Capsules USP, 100 mg.
ANDA 071419...............  Brian Care             Soapco, Inc., P.O.
                             (chlorhexidine         Box 5490,
                             gluconate) Topical     Pleasanton, CA
                             Solution, 4%.          94566.
ANDA 071429...............  Clorazepate            American
                             Dipotassium            Therapeutics, Inc.
                             Capsules, 3.75 mg.
ANDA 071430...............  Clorazepate             Do.
                             Dipotassium
                             Capsules, 7.5 mg.
ANDA 071431...............  Clorazepate             Do.
                             Dipotassium
                             Capsules, 15 mg.
ANDA 071569...............  Danazol Capsules USP,   Do.
                             200 mg.
ANDA 071787...............  Gen-Xene (clorazepate  Alra Laboratories,
                             dipotassium)           Inc.
                             Tablets, 3.75 mg.
ANDA 071788...............  Gen-Xene (clorazepate   Do.
                             dipotassium)
                             Tablets, 7.5 mg.
ANDA 071789...............  Gen-Xene (clorazepate   Do.
                             dipotassium)
                             Tablets, 15 mg.
ANDA 071955...............  Oxazepam Capsules      American
                             USP, 10 mg.            Therapeutics, Inc.
ANDA 071956...............  Oxazepam Capsules       Do.
                             USP, 15 mg.
ANDA 071957...............  Oxazepam Capsules       Do.
                             USP, 30 mg.
ANDA 071962...............  Leucovorin Calcium     Xanodyne Pharmacal,
                             Tablets, EQ 10 mg      Inc.
                             base.
ANDA 071965...............  Ibu-tab (ibuprofen)    Alra Laboratories,
                             Tablets, 800 mg.       Inc.
ANDA 072022...............  Triamterene and        American
                             Hydrochlorothiazide    Therapeutics, Inc.
                             Tablets, 75 mg/50 mg.
ANDA 072129...............  Maprotiline HCl         Do.
                             Tablets USP, 25 mg.
ANDA 072130...............  Maprotiline HCl         Do.
                             Tablets USP, 50 mg.
ANDA 072131...............  Maprotiline HCl         Do.
                             Tablets USP, 75 mg.
ANDA 072190...............  Metaproterenol         Wockhardt EU
                             Sulfate Inhalation     Operations (Swiss)
                             Solution, 5%.          AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 072255...............  Microderm              Johnson and Johnson
                             (chlorhexidine         Medical, Inc., 2500
                             gluconate) Topical     Arbrook Blvd.,
                             Solution, 4%.          Arlington, TX 76014.
ANDA 072292...............  Prevacare R             Do.
                             (chlorhexidine
                             gluconate) Topical
                             Solution, 0.5%.
ANDA 072295...............  Microderm               Do.
                             (chlorhexidine
                             gluconate) Topical
                             Sponge, 4%.
ANDA 072307...............  Fenoprofen Calcium     American
                             Capsules USP, 200 mg.  Therapeutics, Inc.
ANDA 072308...............  Fenoprofen Calcium      Do.
                             Capsules USP, 300 mg.
ANDA 072309...............  Fenoprofen Calcium      Do.
                             Tablets USP, 600 mg.
ANDA 072782...............  Prazosin HCl Capsules   Do.
                             USP, 1 mg.
ANDA 072783...............  Prazosin HCl Capsules   Do.
                             USP, 2 mg.
ANDA 072784...............  Prazosin HCl Capsules   Do.
                             USP, 5 mg.
ANDA 073535...............  Piroxicam Capsules,    Mutual Pharmaceutical
                             10 mg.                 Co., Inc., 1100
                                                    Orthodox St.,
                                                    Philadelphia, PA
                                                    19124.
ANDA 074523...............  Metromidol             Laboratorios
                             (metronidazole)        Applicaciones
                             Tablets, 250 mg and    Farmaceuticas S.A.
                             500 mg.                de CV, c/o Richard
                                                    Hamer Association,
                                                    Inc., P.O. Box
                                                    16598, Fort Worth,
                                                    TX 76162.
ANDA 074560...............  Flurbiprofen Tablets   Theragen, Inc., 10
                             USP, 100 mg.           Lake Dr., East
                                                    Windsor, NJ 08520.
ANDA 074702...............  Metaproterenol         Wockhardt EU
                             Sulfate Syrup, 10 mg/  Operations (Swiss)
                             5 mL.                  AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 074881...............  Iopamidol Injection,   Cook Imaging Corp.,
                             41%, 51%, 61%, and     927 South Curry
                             76%.                   Pike, P.O. Box 3068,
                                                    Bloomington, IN
                                                    47403.
ANDA 075181...............  Prednisolone Sodium    WE Pharmaceuticals,
                             Phosphate Oral         Inc.
                             Solution, EQ 5 mg
                             base/5 mL.

ANDA 075260...............  Tretinoin Topical      Wockhardt EU
                             Solution, 0.05%.       Operations (Swiss)
                                                    AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 075414...............  Nifedipine Extended-   Martec USA, LLC, 1800
                             Release Tablets, 90    North Topping Ave.,
                             mg.                    Kansas City, MO
                                                    64120.
ANDA 075507...............  Ipratropium Bromide    Pharmascience, Inc.,
                             Inhalation Solution,   10 Orchard Pl.,
                             0.02%.                 Tenafly City, NJ
                                                    07670.
ANDA 075569...............  Thallous Chloride TL   Trace Life Sciences,
                             201 Injection USP, 1   Inc., 2101 Shady
                             mCi/mL.                Oaks, Denton, TX
                                                    76205.
ANDA 075586...............  Metaproterenol         Wockhardt EU
                             Sulfate Inhalation     Operations (Swiss)
                             Solution, 0.4% and     AG, c/o Morton Grove
                             0.6%.                  Pharmaceuticals,
                                                    Inc.
ANDA 075619...............  Minoxidil Extra        Avacor Products, LLC,
                             Strength (for Men)     227 East 56th St.,
                             Topical Solution, 5%.  3rd Floor, New York,
                                                    NY 10022.
ANDA 075766...............  Calcitriol Injection,  Fresenius Medical
                             1 microgram (mcg)/mL   Care North America,
                             and 2 mcg/mL.          95 Hayden Ave.,
                                                    Lexington, MA 02421.
ANDA 075941...............  Strontium Chloride SR- Bio-Nucleonics, Inc.,
                             89 Injection, 1 mCi/   1600 Market St.,
                             mL.                    Suite 13200,
                                                    Philadelphia, PA
                                                    19103.
ANDA 077072...............  Ipratropium Bromide    Landela
                             Inhalation Solution,   Pharmaceutical, 776
                             0.02%.                 East Riverside Dr.,
                                                    Suite 150, Eagle, ID
                                                    83616.
ANDA 077218...............  ThyroShield            Arco Pharmaceuticals,
                             (potassium iodide)     LLC, 7605 Maryland
                             Oral Solution USP,     Ave., St. Louis, MO
                             65 mg/mL.              63105.
ANDA 077569...............  Albuterol Sulfate      Landela
                             Inhalation Solution,   Pharmaceutical.
                             EQ 0.083% base.
ANDA 080024...............  Sulfacel-15            Optopics Laboratories
                             (sulfacetamide         Corp., P.O. Box 210,
                             sodium) Ophthalmic     Fairton, NJ 08320.
                             Solution, 15%.
ANDA 080036...............  Sosol (sulfisoxazole)  MK Laboratories,
                             Tablets, 500 mg.       Inc., 424 Grasmere
                                                    Ave., Fairfield, CT
                                                    06430.
ANDA 080366...............  Soxazole               Alra Laboratories,
                             (sulfisoxazole)        Inc.
                             Tablets, 500 mg.
ANDA 080380...............  Bamate (meprobamate)    Do.
                             Tablets, 200 mg and
                             400 mg.
ANDA 080483...............  Hi-cor                 C and M Pharmacal,
                             (hydrocortisone)       Inc., 1519 East 8
                             Cream, 2.5%.           Mile Rd., Hazel
                                                    Park, MI 48030.
ANDA 080492...............  Reserpine Tablets,     Marshall Pharmacal
                             0.1 mg and 0.25 mg.    Corp., 89 Michael
                                                    St., South
                                                    Hackensack, NJ
                                                    07606.
ANDA 080518...............  Dimenhydrinate         Alra Laboratories,
                             Tablets, 50 mg.        Inc.
ANDA 080519...............  Diphenhydramine HCl     Do.
                             Capsules, 25 mg and
                             50 mg.
ANDA 080525...............  Reserpine Tablets,     MK Laboratories, Inc.
                             0.1 mg and 0.25 mg.
ANDA 080592...............  Diphenhydramine HCl    Valeant
                             Capsules, 50 mg.       Pharmaceuticals
                                                    International, One
                                                    Enterprise, Aliso
                                                    Viejo, CA 92656.
ANDA 080660...............  Ocusulf                Miza Pharmaceuticals
                             (sulfacetamide         USA, Inc., c/o
                             sodium) Ophthalmic     Optopics
                             Solution, 10% and      Laboratories, 40
                             30%.                   Main St., P.O. Box
                                                    210, Fairton, NJ
                                                    08320.
ANDA 080714...............  Diphenhydramine HCl    Alra Laboratories,
                             Oral Solution, 12.5    Inc.
                             mg/5 mL.
ANDA 080715...............  Dimenhydrinate Oral     Do.
                             Solution, 12.5 mg/4
                             mL.
ANDA 080941...............  Isoniazid Tablets,     MK Laboratories, Inc.
                             100 mg.
ANDA 080970...............  Methscopolamine        Private Formulations,
                             Bromide Tablets, 2.5   Inc., 460 Plainfield
                             mg.                    Ave., Edison, NJ
                                                    08818.
ANDA 083087...............  Diphenhydramine HCl    MK Laboratories, Inc.
                             Capsules, 25 mg and
                             50 mg.
ANDA 083088...............  Diphenhydramine HCl     Do.
                             Elixir, 12.5 mg/5 mL.
ANDA 083264...............  Pentobarbital Sodium   Valeant
                             Capsules, 100 mg.      Pharmaceuticals
                                                    International.
ANDA 083286...............  Chlorpheniramine       Marshall Pharmacal
                             Maleate Tablets.       Corp.
ANDA 083315...............  Procaine HCl           Elkins Sinn
                             Injection, 1% and 2%.  Pharmaceutical Co.,
                                                    c/o ESI Lederle, 2
                                                    Esterbrook Ln.,
                                                    Cherry Hill, NJ
                                                    08003.
ANDA 083320...............  Acetazolamide          Alra Laboratories,
                             Tablets, 250 mg.       Inc.
ANDA 083389...............  Epinephrine and        Dell Laboratories,
                             Lidocaine HCl          Inc., 668 Front St.,
                             Injection, 0.01 mg/    Teaneck, NJ 07666.
                             mL and 1%.
ANDA 083390...............  Epinephrine and         Do.
                             Lidocaine HCl
                             Injection, 0.01 mg/
                             mL and 2%.
ANDA 083457...............  Vitamin A Palmitate    MK Laboratories, Inc.
                             Capsules, EQ 25,000
                             units base and EQ
                             50,000 units base.
ANDA 083524...............  Butabarbital Sodium    Marshall Pharmacal
                             Tablets, 16.2 mg.      Corp.
ANDA 083525...............  Niacin Tablets, 500    MK Laboratories, Inc.
                             mg.
ANDA 083526...............  Folic Acid Tablets, 1   Do.
                             mg.
ANDA 083658...............  Promethazine HCl       Private Formulations,
                             Tablets, 25 mg.        Inc.
ANDA 083806...............  Dexamethasone          Phoenix Laboratories,
                             Tablets, 0.75 mg.      Inc., 175 Lauman
                                                    Ln., East
                                                    Hicksville, NY
                                                    11801.
ANDA 083827...............  Pramine (imipramine    Alra Laboratories,
                             HCl) Tablets, 10 mg,   Inc.
                             25 mg, and 50 mg.
ANDA 083858...............  Butabarbital Sodium    Marshall Pharmacal
                             Tablets, 32.4 mg.      Corp.
ANDA 083863...............  Sulfisoxazole Cream..  Holland Rantos Co.,
                                                    Inc., P.O. Box 385,
                                                    Piscataway, NJ
                                                    08854.
ANDA 084185...............  Bethanechol Chloride   Wendt Laboratories,
                             Tablets, 10 mg.        Inc., 200 West
                                                    Beaver, P.O. Box
                                                    128, Belle Plaine,
                                                    MN 56011.
ANDA 084186...............  Bethanechol Chloride    Do.
                             Tablets, 25 mg.
ANDA 084188...............  Myotonachol            Glenwood, Inc., 83
                             (bethanechol           North Summit St.,
                             chloride) Tablets, 5   P.O. Box 518,
                             mg, 10 mg, and 25 mg.  Tenafly, NJ 07670.

ANDA 084246...............  Cortisone Acetate      Everylife, 2021 15th
                             Tablets, 25 mg.        Ave., West Seattle,
                                                    WA 98119.
ANDA 084439...............  Prednisolone Tablets,   Do.
                             1 mg, 2.5 mg, and 5
                             mg.
ANDA 084440...............  Prednisone Tablets, 1   Do.
                             mg, 2.5 mg, and 5 mg.
ANDA 084494...............  Hydrochlorothiazide    West-Ward
                             Tablets.               Pharmaceutical Corp.
ANDA 084590...............  Pentobarbital Sodium   Anabolic, Inc., 1835
                             Capsules, 100 mg.      East Cheyenne Rd.,
                                                    Colorado Springs, CO
                                                    80905.
ANDA 084687...............  Niacin Tablets, 500    Zzeon
                             mg.                    Pharmaceuticals,
                                                    Ltd., Jamboree at
                                                    Kevin, Irvine, CA
                                                    92705.
ANDA 084714...............  Hydro-Reserp           ABC Holding Corp.,
                             (hydrochlorothiazide   P.O. Box 307, 70945
                             and reserpine)         Van Dyke Ave.,
                             Tablets, 50 mg/0.125   Romeo, MI 48065.
                             mg.
ANDA 084729...............  Lidocaton              Pharmaton, Ltd., c/o
                             (epinephrine and       Bass Ullmna and
                             lidocaine HCl)         Lustigman, 747 3rd
                             Injection, 0.01 mg/    Ave., New York, NY
                             mL and 2%.             10017.
ANDA 084872...............  Meclizine HCl          CM Bundy Co., 2055
                             Tablets, 25 mg.        Reading Rd.,
                                                    Cincinnati, OH
                                                    45205.
ANDA 084902...............  Promethacon            Polymedica
                             (promethazine HCl)     Industries, Inc., 2
                             Suppository, 50 mg.    Constitution Way,
                                                    Woburn, MA 01801.
ANDA 084931...............  Methamphetamine HCl    Rexar Pharmacal, 396
                             Tablets, 5 mg and 10   Rockaway Ave.,
                             mg.                    Valley Stream, NY
                                                    11581.
ANDA 084933...............  Diethylstilbestrol     West-Ward
                             Tablets, 1 mg.         Pharmaceutical Corp.
ANDA 084977...............  Halothane Inhalation,  BH Chemicals, Inc.,
                             99.99%.                500 5th Ave., New
                                                    York, NY 10036.
ANDA 085009...............  Lygen                  Alra Laboratories,
                             (chlordiazepoxide      Inc.
                             HCl) Capsules, 10 mg.
ANDA 085039...............  Folic Acid Tablets     Wendt Laboratories,
                             USP, 1 mg.             Inc.
ANDA 085040...............  Isoniazid Tablets       Do.
                             USP, 100 mg.
ANDA 085041...............  Meclizine HCl           Do.
                             Tablets, 25 mg.
ANDA 085042...............  Methocarbamol Tablets   Do.
                             USP, 500 mg.
ANDA 085044...............  Reserpine Tablets       Do.
                             USP, 0.25 mg.
ANDA 085075...............  Aerolate III           Fleming and Co.
                             (theophylline)         Pharmaceuticals,
                             Extended-Release       Inc., 1600 Fenton
                             Capsules, 65 mg.       Park Dr., Fenton, MO
                            Aerolate JR             63026.
                             (theophylline)
                             Extended-Release
                             Capsules, 130 mg.
                            Aerolate SR
                             (theophylline)
                             Extended-Release
                             Capsules, 260 mg.
ANDA 085107...............  Lygen                  Alra Laboratories,
                             (chlordiazepoxide      Inc.
                             HCl) Capsules, 5 mg.
ANDA 085108...............  Lygen                   Do.
                             (chlordiazepoxide
                             HCl) Capsules, 25 mg.
ANDA 085125...............  Methyltestosterone     Tablicaps, Inc., P.O.
                             Sublingual Tablets,    Box 5555,
                             10 mg.                 Franklinville, NJ
                                                    08322.
ANDA 085235...............  Chlordiazepoxide HCl   Abbott Laboratories,
                             Capsules.              Pharmaceutical
                                                    Products Division,
                                                    100 Abbott Park Rd.,
                                                    Abbott Park, IL
                                                    60064.
ANDA 085236...............  Chlordiazepoxide HCl    Do.
                             Capsules.
ANDA 085252...............  Meclizine HCl          ABC Holding Corp.
                             Tablets, 25 mg.
ANDA 085253...............  Meclizine HCl           Do.
                             Tablets, 12.5 mg.
ANDA 085282...............  Hydrocortisone         Mericon Industries,
                             Lotion, 0.5% and 1%.   Inc., 8819 North
                                                    Pioneer Rd., Peoria,
                                                    IL 61615.
ANDA 085383...............  Butabarbital Sodium    Wockhardt EU
                             Elixir, 30 mg/5 mL.    Operations (Swiss)
                                                    AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 085411...............  Phentermine HCl        ABC Holding Corp.
                             Capsules, 30 mg.
ANDA 085511...............  Cam-Metrazine           Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 085512...............  Phenazine-35            Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 085550...............  Butabarbital Sodium    CM Bundy Co.
                             Tablets, 30 mg.
ANDA 085569...............  Chlorothiazide         ABC Holding Corp.
                             Tablets, 250 mg.
ANDA 085587...............  Meclizine HCl          Camall Co., Inc.,
                             Chewable Tablets.      60950 Van Dyke Ave.,
                                                    P.O. Box 218,
                                                    Washington, MI
                                                    48094.
ANDA 085672...............  Hydrochlorothiazide    ABC Holding Corp.
                             Tablets, 50 mg.
ANDA 085756...............  Cam-Metrazine          Camall Co., Inc.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 085766...............  Atropine Sulfate and   Private Formulations,
                             Diphenoxylate HCl      Inc.
                             Tablets, 0.025 mg/
                             2.5 mg.
ANDA 085888...............  Brompheniramine        Leiner Health
                             Maleate Tablets.       Products, Inc.
ANDA 085891...............  Meclizine HCl          Anabolic, Inc.
                             Tablets, 25 mg.
ANDA 085895...............  Secobarbital Sodium    Everylife.
                             Capsules, 100 mg.
ANDA 086008...............  Hydrocortisone and     Bioglan Laboratories,
                             Urea Cream, 1%/10%.    Ltd., 450 Hilltop
                                                    Rd., Riegelsville,
                                                    PA 18077.
ANDA 086077...............  Nitrofurazone          Ambix Laboratories,
                             Ointment, 0.2%.        Division of Organics
                                                    Corp. of America.
ANDA 086079...............  Hydrocortisone          Do.
                             Ointment, 1%.
ANDA 086080...............  Hydrocortisone Cream,   Do.
                             1%.
ANDA 086141...............  Tolbutamide Tablets,   Alra Laboratories,
                             500 mg.                Inc.
ANDA 086260...............  Ona-Mast (phentermine  MM Mast and Co.
                             HCl) Tablets, 8 mg.
ANDA 086271...............  Hydrocortisone Cream,  Ambix Laboratories,
                             2.5%.                  Division of Organics
                                                    Corp. of America.
ANDA 086272...............  Hydrocortisone          Do.
                             Ointment, 2.5%.
ANDA 086498...............  Amitriptyline HCl      Alra Laboratories,
                             Tablets, 10 mg.        Inc.
ANDA 086499...............  Amitriptyline HCl       Do.
                             Tablets, 50 mg.
ANDA 086500...............  Amitriptyline HCl       Do.
                             Tablets, 150 mg.
ANDA 086501...............  Amitriptyline HCl       Do.
                             Tablets, 100 mg.
ANDA 086502...............  Amitriptyline HCl       Do.
                             Tablets, 25 mg.
ANDA 086503...............  Amitriptyline HCl       Do.
                             Tablets, 75 mg.

ANDA 086511...............  Ona-Mast (phentermine  MM Mast and Co.
                             HCl) Capsules, 30 mg.
ANDA 086516...............  Ona-Mast (phentermine   Do.
                             HCl) Capsules, 30 mg.
ANDA 086550...............  X-Trozine              Shire Richwood, Inc.,
                             (phendimetrazine       7900 Tanners Gate
                             tartrate) Tablets,     Dr., Suite 200,
                             35 mg.                 Florence, KY 41042.
ANDA 086551...............  X-Trozine               Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 086552...............  X-Trozine               Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 086553...............  X-Trozine               Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 086554...............  X-Trozine               Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 086735...............  Phentermine HCl        Camall Co., Inc.
                             Capsules, 15 mg.
ANDA 086748...............  Theophylline Elixir,   Wockhardt EU
                             80 mg/15 mL.           Operations (Swiss)
                                                    AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 086766...............  Nitrofurazone          Wendt Laboratories,
                             Ointment, 0.2%.        Inc.
ANDA 087081...............  Nitrofurazone Topical   Do.
                             Solution, 0.2%.
ANDA 087226...............  Phentermine HCl        Camall Co., Inc.
                             Capsules, 30 mg.
ANDA 087371...............  X-Trozine L.A.         Shire Richwood, Inc.
                             (phendimetrazine
                             tartrate) Extended-
                             Release Capsules,
                             105 mg.
ANDA 087392...............  Aminophylline          Pharma Serve, Inc.,
                             Injection, 25 mg/mL.   Subsidiary of
                                                    Torigian
                                                    Laboratories, 218-20
                                                    98th Ave., Queens
                                                    Village, NY 11429.
ANDA 087394...............  X-Trozine              Shire Richwood, Inc.
                             (phendimetrazine
                             tartrate) Capsules,
                             35 mg.
ANDA 087442...............  Neosar                 Bedford Laboratories,
                             (cyclophosphamide)     Division of Ben
                             for Injection, 100     Venue Laboratories,
                             mg/vial, 200 mg/       Inc., 300 Northfield
                             vial, 500 mg/vial, 1   Rd., Bedford, OH
                             g/vial, and 2 g/vial.  44146.
ANDA 087487...............  Melfiat-105            Numark Laboratories,
                             (phendimetrazine       Inc., 75 Mayfield
                             tartrate) Extended-    Ave., Edison, NJ
                             Release Capsules,      08837.
                             105 mg.
ANDA 087636...............  Tropicamide            Miza Pharmaceuticals
                             Ophthalmic Solution,   USA, Inc., c/o
                             0.5%.                  Optopics
                                                    Laboratories.
ANDA 087637...............  Tropicamide             Do.
                             Ophthalmic Solution,
                             1%.
ANDA 087681...............  Paracaine              Optopics Laboratories
                             (proparacaine HCl)     Corp.
                             Ophthalmic Solution,
                             0.5%.
ANDA 087764...............  Oby-Trim (phentermine  Shire Richwood, Inc.
                             HCl) Capsules, 30 mg.
ANDA 087932...............  Triamcinolone          Ambix Laboratories,
                             Acetonide Cream,       Division of Organics
                             0.025%.                Corp. of America.
ANDA 088786...............  Sodium Polystyrene     Wockhardt EU
                             Sulfonate USP          Operations (Swiss)
                             Powder, 453.6 g/       AG, c/o Morton Grove
                             bottle.                Pharmaceuticals,
                                                    Inc.
ANDA 088897...............  Promethazine VC Plain   Do.
                             (phenylephrine HCl
                             and promethazine
                             HCl) Syrup, 5 mg/5
                             mL and 6.25 mg/5 mL.
ANDA 089141...............  Aerolate               Fleming and Co.
                             (theophylline) Oral    Pharmaceuticals,
                             Solution, 150 mg/15    Inc.
                             mL.
ANDA 089417...............  Methocarbamol Tablets  American
                             USP, 500 mg.           Therapeutics, Inc.
ANDA 089418...............  Methocarbamol Tablets   Do.
                             USP, 750 mg.
ANDA 089478...............  Acetaminophen and       Do.
                             Codeine Phosphate
                             Tablets USP, 300 mg/
                             15 mg.
ANDA 089479...............  Acetaminophen and       Do.
                             Codeine Phosphate
                             Tablets USP, 300 mg/
                             30 mg.
ANDA 089480...............  Acetaminophen and       Do.
                             Codeine Phosphate
                             Tablets USP, 300 mg/
                             60 mg.
ANDA 089514...............  Trihexyphenidyl HCl    Pharmaceutical
                             Elixir, 2 mg/5 mL.     Ventures, Ltd., P.O.
                                                    Box D3700, Pomona,
                                                    NY 10970.
ANDA 089726...............  Prednisone Oral        Wockhardt EU
                             Solution, 5 mg/5 mL.   Operations (Swiss)
                                                    AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
------------------------------------------------------------------------

    FDA finds that the holders of the ANDAs listed in table 1 have
repeatedly failed to submit reports required by Sec. Sec.  314.81 and
314.98. In addition, under Sec.  314.200, FDA finds that the holders of
the ANDAs have waived any contentions concerning the legal status of
the drug products. Therefore, under these findings, approval of the
ANDAs listed in table 1 and all amendments and supplements thereto, is
hereby withdrawn, effective October 22, 2021.

    Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23075 Filed 10-21-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 172 (Wednesday, September 7, 2022)]
[Rules and Regulations]
[Pages 54615-54618]
[FR Doc No: 2022-19309]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2022-0467]
RIN 1625-AA08

Special Local Regulation; Atlantic Intracoastal Waterway,
Morehead City, NC

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing a temporary special local
regulation (SLR) for certain navigable waters of the Atlantic
Intracoastal Waterway (AICW) and Beaufort Inlet in Morehead City, North
Carolina. This SLR restricts vessel traffic on the AICW and Beaufort
Inlet during high-speed boat races. The restriction of vessel traffic
movement in the SLR is to protect participants and spectators from the
hazards posed by these events. Entry of vessels or persons into this
regulated area is prohibited unless specifically authorized by the
Captain of the Port (COTP) North Carolina or a designated
representative.

DATES: This rule is effective from 10 a.m. on September 9, 2022, until
4 p.m. on September 11, 2022. The SLR will be enforced from 10 a.m. to
4 p.m. on September 9, 2022, and those same hours on September 11,
2022.

ADDRESSES: To view documents mentioned in this preamble as being

available in the docket, go to https://www.regulations.gov, type USCG-
2022-0467 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Ken Farah, Waterways Management Division,
U.S. Coast Guard Sector North Carolina, Wilmington, NC; telephone 910-
772-2221, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it would be impracticable and
contrary to the public interest. The Coast Guard was unable to publish
an NPRM and hold a comment period for this rulemaking due to the short
time period from the event and required publication of this rule.
Immediate action is needed to protect persons and vessels from the
hazards associated with this event. A final rule needs to be in place
by September 10, 2022, to minimize potential danger to the participants
and the public during the event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to public interest
because immediate action is needed to protect persons and vessels from
the hazards associated with this event on September 9 and 11, 2022.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70041. The COTP North Carolina has determined that potential hazards
associated with the Crystal Coast Grand Prix race, scheduled for 10
a.m. through 4 p.m. on September 9, 2022, and those same hours on
September 11, 2022, is a safety concern for mariners during a high
speed boat race on portions of the Atlantic Intra Coastal Waterway
(AICW) and Beaufort Inlet in Morehead City, North Carolina. This rule
is necessary to protect safety of life from the potential hazards
associated with the high-speed boat race.

IV. Discussion of the Rule

    This rule establishes an SLR on a portion of the AICW and Beaufort
Inlet from 10 a.m. on September 9, 2022, until 4 p.m. on September 11,
2022. The SLR will be enforced from 10 a.m. to 4 p.m. on September 9,
2022, and those same hours on September 11, 2022. The time of
enforcement will be broadcast locally over VHF-FM marine radio.
    The regulated area encompases approximately 1.5 square miles and
will include all navigable waters of the AICW and Beaufort Inlet, North
Carolina, from approximate positions: latitude 34[deg]42'55'' N,
longitude 076[deg]43'15'' W, then east to latitude 34[deg]42'56'' N,
longitude 076[deg]42'13'' W, then east to latitude 34[deg]42'57'' N,
longitude 076[deg]41'41'' W, then east to latitude 34[deg]42'57'' N,
longitude 076[deg]41'25'' W, then south east to latitude 34[deg]42'23''
N, longitude 076[deg]40'44'' W, then south to latitude 34[deg]41'59''
N, longitude 076[deg]40'43'' W, then north west to latitude
34[deg]42'32'' N, longitude 076[deg]42'14'' W, then west to latitude
34[deg]42'32'' N, longitude 076[deg]43'15'' W, then north to its point
of origin.
    This SLR provides additional information about areas within the
regulated area and their definitions. These areas include ``Race
Area,'' ``Spectator Area,'' and ``Buffer Area.''
    The size of the regulated area is intended to ensure the safety of
life on these navigable waters before, during, and after activities
associated with the boat race, scheduled from 10 a.m. to 4 p.m. on
September 9, 2022, and September 11, 2022. The COTP and the Coast Guard
Event Patrol Commander (PATCOM) have authority to forbid and control
the movement of all vessels and persons, including event participants,
in the regulated area. When hailed or signaled by an official patrol, a
vessel or person in the regulated area must immediately comply with the
directions given by the COTP or Event PATCOM. If a person or vessel
fails to follow such directions, the Coast Guard may expel them from
the area, issue them a citation for failure to comply, or both.
    Except for Crystal Coast Grand Prix race participants and vessels
already at berth, a vessel or person must get permission from the COTP
or Event PATCOM to remain in the regulated area and before entering the
regulated area. Vessel operators must request permission to enter and
transit through the regulated area by contacting the Event PATCOM on
VHF-FM channel 16. Vessel traffic will be able to safely transit the
regulated area once the Event PATCOM deems it safe to do so. A vessel
within the regulated area must operate at safe speed that minimizes
wake. A person or vessel not registered with the event sponsor as a
participant or assigned as official patrols will be considered a
spectator. Official Patrols are any vessel assigned or approved by the
Commander, Coast Guard Sector North Carolina with a commissioned,
warrant, or petty officer on board and displaying a Coast Guard ensign.
Official Patrols enforcing this regulated area can be contacted on VHF-
FM channel 16 and channel 22A.
    If permission is granted by the COTP or Event PATCOM, a person or
vessel will be allowed to enter the regulated area or pass directly
through the regulated area as instructed. Vessels must operate at a
safe speed that minimizes wake while within the regulated area. A
spectator vessel must not loiter within the Race area, Buffer Zone, or
navigable channel while within the regulated area. Official patrol
vessels will direct spectators to the designated spectator area. Only
participant vessels will be allowed to enter the Race Area, and the
Buffer Zone, if necessary.
    The duration of this SLR is intended to protect participants and
spectators on the navigable waters of the AICW and Beafort Inlet during
the high-speed boat race. Vessels may request permission to pass
through the SLR between race heats. No vessel or person will be
permitted to enter the SLR without obtaining permission from the COTP
North Carolina or a designated representative. The regulatory text
appears at the end of this document.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and

benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits.
This rule has not been designated a ``significant regulatory action,''
under Executive Order 12866. Accordingly, this rule has not been
reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, and duration of the SLR. Vessel traffic will not be allowed
to enter or transit a portion of the AICW or Beaufort Inlet during an
active race event from 10 a.m. through 4 p.m. on both September 10,
2022, and September 12, 2022. The Coast Guard will transmit a Broadcast
Notice to Mariners via VHF-FM marine channel 16 regarding the
enforcement period of the SLR. This rule allows vessels to request
permission to pass through the regulated area between race heats.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule will affect your small
business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves an SLR
to be enforced during active race events. It will be enforced a total
of 6 hours while in effect. It is categorically excluded from further
review under paragraph L61 of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1. A Memorandum for Record supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T05-0467 to read as follows:

Sec.  100.T05-0467  Crystal Coast Grand Prix, Morehead City, NC.

    (a) Regulated areas. The regulations in this section apply to the
following areas:
    (1) Race area. The race area is all navigable waters of the
Atlantic Intracoastal Waterway (AICW) and Beaufort Inlet, North
Carolina, from approximate positions: latitude 34[deg]42'52'' N,
longitude 076[deg]43'16'' W, then east to latitude 34[deg]42'52.2'' N,
longitude 076[deg]42'11.04'' W, then east to latitude 34[deg]42'53.76''
N, longitude 076[deg]41'38.04'' W, then southeast to latitude
34[deg]42'10.8'' N, longitude 076[deg]40'44.4'' W, then south to
latitude 34[deg]42'4.3'' N, longitude 076[deg]40'48.1'' W, then
northwest to latitude 34[deg]42'47.34'' N, longitude 076[deg]41'49'' W,
then west to latitude 34[deg]42'50'' N, longitude 076[deg]43'16'' W,
then north to the point of origin.

    (2) Spectator area. The spectator area is all waters of the AICW,
North Carolina, from approximate positions: latitude 34[deg]42'42'' N,
longitude 076[deg]43'15'' W, then east to latitude 34[deg]42'41'' N,
longitude 076[deg]42'14'' W, then south to latitude 34[deg]42'32'' N,
longitude 076[deg]42'14'' W, then west to latitude 34[deg]42'32'' N,
longitude 076[deg]43'15'' W, then north to the point of origin.
    (3) Buffer area. The buffer area is all waters of the AICW and
Beaufort Inlet, North Carolina, from approximate positions: latitude
34[deg]42'55'' N, longitude 076[deg]43'15'' W, then east to latitude
34[deg]42'56'' N, longitude 076[deg]42'13'' W, then east to latitude
34[deg]42'57'' N, longitude 076[deg]41'41'' W, then east to latitude
34[deg]42'57'' N, longitude 076[deg]41'25'' W, then south east to
latitude 34[deg]42'23'' N, longitude 076[deg]40'44'' W, then south to
latitude 34[deg]41'59'' N, longitude 076[deg]40'43'' W, then north west
to latitude 34[deg]42'41'' N, longitude 076[deg]42'05'' W, then west to
latitude 34[deg]42'42'' N, longitude 076[deg]43'15'' W, then north to
its point of origin.
    (b) Definitions. As used in this section--
    Buffer area is a neutral area that surrounds the perimeter of the
race area within the regulated area described by this section. The
purpose of a buffer area is to minimize potential collision conflicts
with marine event participants and spectator vessels or nearby
transiting vessels. This area provides separation between a race area
and a specified spectator area or other vessels that are operating in
the vicinity of the regulated area established by the special local
regulation (SLR) in this section.
    Captain of the Port means the Commander, Sector North Carolina.
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard commissioned, warrant, or petty officer
designated by the Captain of the Port North Carolina (COTP) for the
enforcement of the safety zone.
    Spectator means a person or vessel not registered with the event
sponsor as participants or assigned as official patrols.
    Spectator area is an area described by a line bound by coordinates
provided in latitude and longitude that outlines the boundary of a
spectator area within the regulated area defined by paragraph (a)(2) of
this section.
    (c) Regulations. (1) Everyone other than participants are
prohibited from entering, transiting through, anchoring in, or getting
underway within the regulated area described in the race area in
paragraph (a)(1) of this section unless authorized by the COTP North
Carolina or their designated representative.
    (2) Everyone other than participants, including spectators, may be
directed by a designated representative to the regulated area described
in paragraph (a) of this section, where they must remain while the SLR
in this section is being enforced unless otherwise authorized or
directed by a designated representative.
    (3) To seek permission to enter the regulated area, contact the
COTP by calling the Sector North Carolina Command Center at 910-343-
3882 or contact the COTP's designated representative on Marine band
Radio, VHF-FM channel 16 (156.8 MHz). Those in the regulated area must
comply with all lawful orders or directions given to them by the COTP
or the designated representative.
    (d) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the safety zone by Federal, State, and
local agencies.
    (e) Enforcement. The SLR in this section will be enforced from 10
a.m. through 4 p.m. on September 9, 2022, and those same hours on
September 11, 2022.

    Dated: August 30, 2022.
Matthew J. Baer,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2022-19309 Filed 9-6-22; 8:45 am]
BILLING CODE 9110-04-P