← FDA DRUG APPROVALS

FDA NDA · NDA204119

EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor: HETERO DRUGS LTD

APPLICATION
NDA204119
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATENone (Tentative Approval)
EFAVIRENZ 600MG, LAMIVUDINE 300MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2017-06-30Type 4 - New Combination · Original · priority — 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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