FDA NDA · NDA021974

LAMIVUDINE; STAVUDINE

Sponsor: CIPLA LIMITED

APPLICATION

NDA021974

TYPE

NDA

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

None (Tentative Approval)

Products

LAMIVUDINE; STAVUDINENone (Tentative Approval)

LAMIVUDINE 150MG, STAVUDINE 40MG · TABLET · ORAL

LAMIVUDINE; STAVUDINENone (Tentative Approval)

LAMIVUDINE 150MG, STAVUDINE 30MG · TABLET · ORAL

2007-01-19Type 4 - New Combination · Original · priority — Letter ↗TA

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

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.