APPLICATION
ANDA091144
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-28
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ABACAVIR SULFATE AND LAMIVUDINEPrescription
ABACAVIR SULFATE EQ 600MG BASE, LAMIVUDINE 300MG · TABLET · ORAL
Approval history
2023-06-07Labeling · Supplement 21 · standardAP
2023-06-07Labeling · Supplement 18 · standardAP
2019-07-25Labeling · Supplement 15 · standardAP
2019-07-25Labeling · Supplement 13 · 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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