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FEDERAL REGISTER · NOTICEDecember 12, 2025NOTICE — NO LEGAL EFFECT

Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

Document type
Notice
Agency
Health and Human Services Department
Published
December 12, 2025
Document number
2025-22683
ABSTRACT

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Abstract as published in the Federal Register.

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