← FDA DRUG APPROVALS

FDA ANDA · ANDA091215

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA091215
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-09
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EFAVIRENZ 600MG, EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 6 · standardAP
2024-03-09Labeling · Supplement 2 · standardAP
2018-11-09OriginalAP
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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