Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction
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Abstract
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 Reddy's Laboratories, Inc., withdrawn as of November 3, 2023.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 Reddy's Laboratories, Inc., informed FDA that it did not want the approval of the ANDA withdrawn.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 Reddy's Laboratories, Inc., timely requested that approval of ANDA 203807 not be withdrawn, the approval is still in effect.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.
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<title>Federal Register, Volume 88 Issue 235 (Friday, December 8, 2023)</title>
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[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85628-85629]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 Reddy's Laboratories, Inc., withdrawn as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, <a href="/cdn-cgi/l/email-protection#f4b99586809c95daba93818d919ab4929095da9c9c87da939b82"><span class="__cf_email__" data-cfemail="afe2cedddbc7ce81e1c8dad6cac1efc9cbce81c7c7dc81c8c0d9">[email protected]</span></a>.
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]
BILLING CODE 4164-01-P
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