Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction

---
identifier: "/us/fr/2023-26994"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2023-26994"
section_name: "Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction"
positive_law: false
currency: "2023-12-08"
last_updated: "2023-12-08"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2023-26994"
document_type: "notice"
publication_date: "2023-12-08"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "88 FR 85628"
fr_volume: 88
docket_ids:
  - "Docket No. FDA-2023-N-3859"
fr_action: "Notice; correction."
---


#  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 Reddy's Laboratories, Inc., withdrawn as of November 3, 2023.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 Reddy's Laboratories, Inc., informed FDA that it did not want the approval of the ANDA withdrawn.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 Reddy's Laboratories, Inc., timely requested that approval of ANDA 203807 not be withdrawn, the approval is still in effect.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, *[email protected].*

**SUPPLEMENTARY INFORMATION:**

In the *Federal Register* of Wednesday, October 4, 2023 (88 FR 68628), appearing on  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.