APPLICATION
ANDA090159
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-15
LATEST ACTION
2023-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ABACAVIR SULFATE AND LAMIVUDINEPrescription
ABACAVIR SULFATE EQ 600MG BASE, LAMIVUDINE 300MG · TABLET · ORAL
Approval history
2023-04-18Labeling · Supplement 4 · standardAP
2023-04-18Labeling · Supplement 7 · standardAP
2020-01-07Labeling · Supplement 2 · standardAP
2018-11-15OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.