Document ID: FDA-2021-N-0492-0002
Agency: fda
Document Type: Notice
Title: Watson Laboratories, Inc., et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications; Correction
Posted Date: 2021-10-01T04:00Z

[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Page 54450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21371]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0492]

Watson Laboratories, Inc., et al.; Withdrawal of Approval of 36 
Abbreviated 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 of June 25, 2021. The document 
announced the withdrawal of approval of 36 abbreviated new drug 
applications (ANDAs) from multiple applicants as of July 26, 2021. The 
document indicated that FDA was withdrawing approval of the following 
ANDA, after receiving a withdrawal request from Yung Shin 
Pharmaceutical Ind. Co. Ltd., authorized U.S. agent, Carlsbad 
Technology, Inc./Simon Law, 5922 Farnsworth Ct., Suite 101, Carlsbad, 
CA 92008: ANDA 065152, Cephalexin Capsules, Equivalent to (EQ) 250 
milligrams (mg) base and EQ 500 mg base. Before FDA withdrew the 
approval of this ANDA, Yung Shin Pharmaceutical Ind. Co. Ltd. informed 
FDA that it did not want the approval of the ANDA withdrawn. Because 
Yung Shin Pharmaceutical Ind. Co. Ltd. timely requested that approval 
of this ANDA not be withdrawn, the approval of ANDA 065152 is still in 
effect.

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, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 25, 
2021 (86 FR 33718), FR Doc. 2021-13593, the following correction is 
made:
    On page 33718, in the table, the entry for ANDA 065152 is removed.

    Dated: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21371 Filed 9-30-21; 8:45 am]
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