← FDA DRUG APPROVALS

FDA NDA · NDA204568

EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor: CIPLA

APPLICATION
NDA204568
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

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

Approval history

2013-12-30Type 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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