← FDA DRUG APPROVALS

FDA NDA · NDA022343

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
NDA022343
TYPE
NDA
ORIGINAL APPROVAL
2018-08-15
LATEST ACTION
2018-08-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE · ReferenceDiscontinued
EFAVIRENZ 600MG, LAMIVUDINE 300MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2018-08-15Type 4 - New Combination · Original · standard — Letter ↗AP
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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