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FDA ANDA · ANDA205412

ABACAVIR AND LAMIVUDINE

Sponsor: HETERO LABS LTD V

APPLICATION
ANDA205412
TYPE
ANDA
ORIGINAL APPROVAL
2025-04-16
LATEST ACTION
2025-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ABACAVIR SULFATE AND LAMIVUDINEPrescription
ABACAVIR SULFATE EQ 600MG BASE, LAMIVUDINE 300MG · TABLET · ORAL

Approval history

2025-04-16UNKNOWN · Original · standardLetterAP
2015-12-22Labeling · Supplement 1 · standardAP
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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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