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Product safetyFDAUnited StatesImports

Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications

9 October 2026

In plain English

FDA is withdrawing approval of 37 ANDAs from multiple applicants, including Par Health USA LLC as U.S. agent for PH Health Limited, after they reported the drugs are no longer marketed.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
9 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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