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FDA NDA · NDA215448

DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE

Sponsor: AUROBINDO PHARMA USA

APPLICATION
NDA215448
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDENone (Tentative Approval)
DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE 50MG/200MG/25MG · TABLET · ORAL

Approval history

2023-05-26Type 4 - New Combination · Original · standard — Letter ↗TA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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