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FDA approval · 2022-01-03

FDA Approved: PIRFENIDONE — Original Application (Amneal Pharmaceuticals NY LLC)

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Summary

FDA approved a generic version of pirfenidone (ANDA 212569) for idiopathic pulmonary fibrosis, manufactured by Amneal Pharmaceuticals NY LLC.

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Diseases / indications

Drugs mentioned

  • PIRFENIDONE (pirfenidone)

Snippet

ORIG AP for PIRFENIDONE (PIRFENIDONE)