88 FR 235 pgs. 85628-85629 - Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction
Type: NOTICEVolume: 88Number: 235Pages: 85628 - 85629
Pages: 85628, 85629Docket number: [Docket No. FDA–2023–N–3859]
FR document: [FR Doc. 2023–26994 Filed 12–7–23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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 Reddy's Laboratories, Inc., withdrawn as of November 3, 2023.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 Reddy's Laboratories, Inc., informed FDA that it did not want the approval of the ANDA withdrawn.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 Reddy's Laboratories, Inc., timely requested that approval of ANDA 203807 not be withdrawn, the approval is still in effect.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, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[top] In the Federal Register of Wednesday, October 4, 2023 (88 FR 68628), appearing on
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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