# 2025-00742: Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications

2025-00742, Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications, is a Federal Register notice from an unnamed agency published 2025-01-15, effective 2025-02-14 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-00742
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-00742
- Title: Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
- Type: Notice
- Agencies: unknown
- Citation: unknown
- Published: 2025-01-15
- Effective: 2025-02-14
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## Summary

The FDA is officially pulling the plug on 23 drug approvals because the companies told them these medicines aren’t being sold anymore. This change affects several drug makers, including Teva and Sandoz, and takes effect on February 14, 2025. No money penalties here—companies just asked to close these files, but they can always apply again if they want.

## Abstract

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

## Effects PRIA read

- Approval withdrawn for 23 ANDAs: cost, medium. The FDA is withdrawing approval of 23 abbreviated new drug applications (ANDAs) as of February 14, 2025. The notice names multiple applicants (for example, Teva and Sandoz) and says approval of each entire application is withdrawn, including any strengths or dosage forms; introducing those products…
- Existing inventory may still be dispensed: benefit, low. Drug products listed in the notice that are in inventory on February 14, 2025 may continue to be dispensed until those inventories are depleted, the products reach their expiration dates, or they otherwise become violative, whichever occurs first. This provides a temporary continuation of access fr…

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## Sources
- [2025-00742 on federalregister.gov](https://www.federalregister.gov/documents/2025/01/15/2025-00742/teva-pharmaceuticals-usa-inc-et-al-withdrawal-of-approval-of-23-abbreviated-new-drug-applications)
- [2025-00742 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-01-15/pdf/2025-00742.pdf)

## Related
- [Previous: 2025-00741, Agency Information Collection Activities; Submission to the Office of Managemen…](https://policyrisk.com/federal-register/2025-00741)
- [Next: 2025-00743, Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval…](https://policyrisk.com/federal-register/2025-00743)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-00742 (as of 2026-06-08).