← FDA DRUG APPROVALS

FDA NDA · NDA213509

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Sponsor: MYLAN

APPLICATION
NDA213509
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE 400MG · TABLET · ORAL

Approval history

2024-03-22Type 4 - New Combination · Original · standardLetterTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →