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FDA approval · 2023-08-21

FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

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Summary

FDA approved a supplemental application for fluoxetine hydrochloride (ANI Pharmaceuticals, Inc.), indicating approval of changes to an already approved product.

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Diseases / indications

Drugs mentioned

  • Fluoxetine hydrochloride (Fluoxetine hydrochloride)

Snippet

SUPPL AP for FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE)