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FDA NDA · NDA219804

DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE

Sponsor: ASPEN SA OPERATIONS (PTY) LTD

APPLICATION
NDA219804
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATENone (Tentative Approval)
DOLUTEGRAVIR 50MG/300MG/300MG, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE · TABLET · ORAL

Approval history

2026-05-07Type 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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