← FDA DRUG APPROVALS

FDA NDA · NDA021969

LAMIVUDINE; STAVUDINE; NEVIRAPINE

Sponsor: CIPLA LIMITED

APPLICATION
NDA021969
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

LAMIVUDINE; STAVUDINE; NEVIRAPINENone (Tentative Approval)
LAMIVUDINE 150MG, STAVUDINE 30MG, NEVIRAPINE 200MG · TABLET · ORAL
LAMIVUDINE; STAVUDINE; NEVIRAPINENone (Tentative Approval)
LAMIVUDINE 150MG, STAVUDINE 40MG, NEVIRAPINE 200MG · TABLET · ORAL

Approval history

2006-11-17Type 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 →