[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Page 73483]
[FR Doc No: 2020-25413]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5843]

Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19
New Drug Applications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register on January 8, 2020. The document
announced the withdrawal of approval of 19 new drug applications (NDAs)
from multiple applicants, withdrawn as of February 7, 2020. The
document indicated that FDA was withdrawing approval of NDA 202342,
Esomeprazole Strontium Delayed-Release Capsules, Equivalent to (EQ) 20
milligrams (mg) base and EQ 40 mg base, after receiving a withdrawal
request from R2 Pharma, LLC, 11550 North Meridian St., Suite 290,
Carmel, IN 46032-5505 (R2 Pharma). Because of clerical errors in the
Agency's processing of communications regarding this application, FDA
has determined that NDA 202342 remains approved. Accordingly, FDA's
approval of NDA 202342 remains in effect. There are no changes with
respect to the other 18 NDA withdrawals announced in the January 8,
2020 Federal Register notice.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of Wednesday, January 8, 2020 (85 FR 915),
appearing on page 916 in FR Doc. 2020-00075, the following correction
is made:
    On page 916, in the table, the entry for NDA 202342 is removed.

    Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25413 Filed 11-17-20; 8:45 am]
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