← FDA DRUG APPROVALS

FDA NDA · NDA202685

LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

Sponsor: STRIDES ARCOLAB LTD

APPLICATION
NDA202685
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
None (Tentative Approval)

Products

LAMIVUDINE; NEVIRAPINE; ZIDOVUDINENone (Tentative Approval)
LAMIVUDINE 30MG, NEVIRAPINE 50MG, ZIDOVUDINE 60MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2012-09-21Type 3 - New Dosage Form and Type 4 - New Combination · Original · standardLetterTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →