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FDA approval · 2022-05-10

FDA Approved: ROFLUMILAST — Original Application (Solco Healthcare US, LLC.)

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Summary

FDA approved the original ANDA for roflumilast by Solco Healthcare US, LLC, authorizing a generic version of the COPD medication.

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Diseases / indications

Drugs mentioned

  • Roflumilast (roflumilast)

Snippet

ORIG AP for ROFLUMILAST (ROFLUMILAST)