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FDA approval · 2023-04-18

FDA Approved: ROFLUMILAST — Original Application (Ascend Laboratories, LLC)

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Summary

FDA approved an original ANDA for roflumilast from Ascend Laboratories, making a generic version of this COPD medication available.

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Diseases / indications

Drugs mentioned

  • Roflumilast (roflumilast)

Snippet

ORIG AP for ROFLUMILAST (ROFLUMILAST)