[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Notices]
[Page 44096]
[FR Doc No: 2020-15727]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1227]

Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of
10 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 10 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 20, 2020.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
      Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 060709...............  Oleandomycin           Roerig Division of
                             Injection.             Pfizer Inc., 235
                                                    East 42nd St., New
                                                    York, NY 10017.
ANDA 061087...............  Benzocaine,            Pfizer Laboratories,
                             Oxytetracycline        Division of Pfizer
                             Hydrochloride (HCl),   Inc., 235 East 42nd
                             and Polymyxin B        St., New York, NY
                             Sulfate Otic           10017.
                             Solution.
ANDA 061725...............  Tetracycline HCl       Warner Chilcott
                             Capsules, 250          Division of Warner
                             milligrams (mg) and    Lambert-Pfizer,
                             500 mg.                Inc., 235 East 42nd
                                                    St., New York, NY
                                                    10017.
ANDA 061943...............  Chloramphenicol        Lederle Laboratories,
                             Ophthalmic Solution,   Division of American
                             0.5%.                  Cyanamid Co., 1
                                                    Cyanamid Plaza,
                                                    Wayne, NJ 07470.
ANDA 062175...............  Tetracycline HCl       Warner Chilcott
                             Capsules, 250 mg.      Division of Warner
                                                    Lambert-Pfizer, Inc.
ANDA 062215...............  Oxytetracycline HCl    Lederle Laboratories,
                             Capsules.              Division of American
                                                    Cyanamid Co.
ANDA 076203...............  Ribavirin Capsules,    Kadmon
                             200 mg.                Pharmaceuticals,
                                                    LLC, 119
                                                    Commonwealth Dr.,
                                                    Warrendale, PA
                                                    15086.
ANDA 077456...............  Ribavirin Tablets,     Do.
                             200 mg, 400 mg, and
                             600 mg.
ANDA 084669...............  Chlorpropamide         Sandoz Inc., 2555 W.
                             Tablets, 250 mg.       Midway Blvd.,
                                                    Broomfield, CO
                                                    80038.
ANDA 201750...............  Articaine HCI and      Hansamed Ltd., 4761
                             Epinephrine            Tara Ct., West
                             Bitartrate for         Bloomfield, MI
                             Injection, 4%;         48323.
                             Equivalent to (EQ)
                             0.017 mg base/1.7
                             milliliters (mL);
                             (4%; EQ 0.01 mg base/
                             mL).
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 20, 2020. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on August 20, 2020 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: July 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15727 Filed 7-20-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Page 31916]
[FR Doc No: 2013-12507]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL13-65-000; QF90-143-006]

Yuma Cogeneration Associates; Notice of Filing

    Take notice that on May 17, 2013, pursuant to section 292.205(c) of
the regulations of the Federal Energy Regulatory Commission
(Commission) implementing the Public Utility Regulatory Policies Act of
1978 (PURPA), Yuma Cogeneration Associates (Yuma Cogeneration)
submitted a petition for a limited waiver of the efficiency standard in
section 292.205(a)(2) of the Commission's regulations for a topping-
cycle cogeneration qualifying facility (QF) located in Yuma, Arizona
for the calendar years 2010, 2011, and 2012.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on June 7, 2013.

    Dated: May 20, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-12507 Filed 5-24-13; 8:45 am]
BILLING CODE 6717-01-P