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FDA approval · 2025-01-31

FDA Approved: ROFLUMILAST — Supplemental Application (Aurobindo Pharma Limited)

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Summary

The FDA approved a supplemental application for roflumilast filed by Aurobindo Pharma Limited under ANDA213298, enabling a generic roflumilast product to enter …

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Diseases / indications

Drugs mentioned

  • Roflumilast (roflumilast)

Snippet

SUPPL AP for ROFLUMILAST (ROFLUMILAST)