Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correction

---
identifier: "/us/fr/2025-19440"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2025-19440"
section_name: "Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correction"
positive_law: false
currency: "2025-10-03"
last_updated: "2025-10-03"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2025-19440"
document_type: "notice"
publication_date: "2025-10-03"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "90 FR 48056"
fr_volume: 90
docket_ids:
  - "Docket No. FDA-2025-N-2422"
fr_action: "Notice; correction."
---


#  Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 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 August 4, 2025 (90 FR 36440). The document announced the withdrawal of approval of 39 new drug applications (NDA) from multiple applicants, withdrawn as of September 3, 2025. The document erroneously included NDA number 021290. The correct NDA number is 020212 for Zinecard (dexrazoxane hydrochloric acid (HCl)) Injectable, equivalent to (EQ) 250 milligrams (mg) base/vial and EQ 500 mg base/vial. This document corrects that error.

**FOR FURTHER INFORMATION CONTACT:**

Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-796-3137, *[email protected].*

**SUPPLEMENTARY INFORMATION:**

In the *Federal Register* issue published August 4, 2025 (90 FR 36440), the NDA number for Zinecard (dexrazoxane HCl) Injectable, EQ 250 mg base/vial and EQ 500 mg base/vial is corrected to 020212.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.