← FDA DRUG APPROVALS

FDA NDA · NDA214544

DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE

Sponsor: LUPIN LTD

APPLICATION
NDA214544
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

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

Approval history

2023-01-19Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →