APPLICATION
ANDA204990
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-28
LATEST ACTION
2024-06-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ABACAVIR SULFATE AND LAMIVUDINEPrescription
ABACAVIR SULFATE EQ 600MG BASE, LAMIVUDINE 300MG · TABLET · ORAL
Approval history
2024-06-14Labeling · Supplement 11 · standardAP
2020-02-24Labeling · Supplement 6 · standardAP
2020-02-24Labeling · Supplement 4 · standardAP
2020-02-24Manufacturing (CMC) · Supplement 7 · unknownAP
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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