← FDA DRUG APPROVALS

FDA NDA · NDA021838

STAVUDINE; LAMIVUDINE

Sponsor: STRIDES ACROLAB

APPLICATION
NDA021838
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

STAVUDINE; LAMIVUDINENone (Tentative Approval)
STAVUDINE 40MG, LAMIVUDINE 150MG · TABLET · ORAL

Approval history

2007-03-13Type 4 - New Combination · Original · priorityLetterTA
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 →