FDA Approved: ROFLUMILAST — Original Application (Zydus Pharmaceuticals USA Inc.)

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Summary

FDA approved the original ANDA for a generic roflumilast from Zydus Pharmaceuticals USA Inc., enabling a generic version of the COPD medication.

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Diseases / indications

• Chronic Obstructive Pulmonary Disease

Drugs mentioned

• Roflumilast (roflumilast)

Snippet

ORIG AP for ROFLUMILAST (ROFLUMILAST)