Document ID: FDA-2023-N-3859-0002
Agency: fda
Document Type: Notice
Title: Dr. Reddy’s Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction
Posted Date: 2023-12-08T05:00Z

[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85628-85629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26994]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3859]

Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 
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 on October 4, 2023. The document 
announced the withdrawal of approval of 11 abbreviated new drug 
applications (ANDAs) from Dr. Reddy's Laboratories, Inc., withdrawn as 
of November 3, 2023. The document indicated that FDA was withdrawing 
approval of ANDA 203807, clozapine tablets, 25 milligrams (mg), 50 mg, 
100 mg, and 200 mg, held by Dr. Reddy's Laboratories, Inc., U.S. Agent 
for Dr. Reddy's Laboratories SA, 107 College Rd. East, Princeton, NJ 
08540. Before FDA withdrew the approval of this ANDA, Dr. Reddy's 
Laboratories, Inc., informed FDA that it did not want the approval of 
the ANDA withdrawn. Because Dr. Reddy's Laboratories, Inc., timely 
requested that approval of ANDA 203807 not be withdrawn, the approval 
is still in effect. This notice corrects that error.

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 protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday, 
October 4, 2023 (88 FR 68628), appearing on

[[Page 85629]]

page 68629 in FR Doc. 2023-21992, the following correction is made:
    On page 68629, in the table, the entry for ANDA 203807 is removed.

    Dated: December 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26994 Filed 12-7-23; 8:45 am]
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