APPLICATION
ANDA091294
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-18
LATEST ACTION
2023-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ABACAVIR SULFATEPrescription
ABACAVIR SULFATE EQ 300MG BASE · TABLET · ORAL
Approval history
2023-04-25Labeling · Supplement 10 · standardAP
2015-12-11Manufacturing (CMC) · Supplement 3 · unknownAP
2015-12-11Labeling · Supplement 1 · standardAP
2015-12-11Labeling · Supplement 4 · standardAP
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.