← FDA DRUG APPROVALS

FDA NDA · NDA200793

LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS

Sponsor: MATRIX LABS

APPLICATION
NDA200793
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
None (Tentative Approval)

Products

LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETSNone (Tentative Approval)
Lamivudine 30MG, Nevirapine 50MG, Zidovudine 60MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2010-07-08Type 3 - New Dosage Form and Type 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.

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 →