FDA Approved: ITRACONAZOLE — Supplemental Application (Ascend Laboratories, LLC)

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Summary

FDA approved a supplemental application for itraconazole from Ascend Laboratories, LLC, authorizing changes to the generic product under ANDA 208591.

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Diseases / indications

• Aspergillosis
• Blastomycosis
• Coccidioidomycosis
• Histoplasmosis
• Onychomycosis
• Sporotrichosis

Drugs mentioned

• Itraconazole (Itraconazole)

Snippet

SUPPL AP for ITRACONAZOLE (ITRACONAZOLE)