FDA NDA · NDA204915

ABACAVIR AND LAMIVUDINE

Sponsor: MYLAN LABS LTD

APPLICATION

NDA204915

TYPE

NDA

ROUTE

ORAL SUSPENSION

DOSAGE FORM

TABLET

MARKETING STATUS

None (Tentative Approval)

Products

ABACAVIR AND LAMIVUDINENone (Tentative Approval)

ABACAVIR 120MG, LAMIVUDINE 60MG · TABLET · ORAL SUSPENSION

2014-10-23Type 3 - New Dosage Form · Original · standard — 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.