FDA Tentative Approval: DARUNAVIR — Original Application (Amneal Pharmaceuticals NY LLC)

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Summary

FDA issued tentative approval for Amneal Pharmaceuticals NY LLC's generic darunavir (DARUNAVIR) under an ANDA, permitting marketing for HIV-1 infection subject …

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Diseases / indications

• HIV Infection

Drugs mentioned

• Darunavir (darunavir)

Snippet

ORIG TA for DARUNAVIR (DARUNAVIR)