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FDA ANDA · ANDA079246

ABACAVIR SULFATE AND LAMIVUDINE

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA079246
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-29
LATEST ACTION
2023-06-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-06-21Labeling · Supplement 11 · standardAP
2020-11-12Labeling · Supplement 6 · standardAP
2020-11-12Labeling · Supplement 4 · standardAP
2020-11-12Labeling · Supplement 9 · standardAP
2016-09-29OriginalLetterAP
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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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