← FDA DRUG APPROVALS

FDA NDA · NDA210649

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor: MACLEODS PHARMS LTD

APPLICATION
NDA210649
TYPE
NDA
ORIGINAL APPROVAL
2019-03-15
LATEST ACTION
2019-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEDiscontinued
EFAVIRENZ 400MG, LAMIVUDINE 300MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2019-03-15Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗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.

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 →