APPLICATION
ANDA091050
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-28
LATEST ACTION
2023-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ABACAVIR SULFATEPrescription
ABACAVIR SULFATE EQ 300MG BASE · TABLET · ORAL
Approval history
2023-04-28Labeling · Supplement 12 · standardAP
2023-04-28Labeling · Supplement 10 · standardAP
2023-04-28Labeling · Supplement 11 · 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.
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