Document ID: FDA-2019-N-5843-0002
Agency: fda
Document Type: Notice
Title: Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications; Correction
Posted Date: 2020-11-18T05:00Z

[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Page 73483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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from multiple applicants, withdrawn as of February 7, 2020.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, Kimberly.Lehrfeld@fda.hhs.gov.

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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