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FDA ANDA · ANDA079094

BUPROPION HYDROCHLORIDE SR

bupropion hydrochloride

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA079094
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-24
LATEST ACTION
2025-11-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-11-06Labeling · Supplement 44 · standardAP
2024-05-07Labeling · Supplement 36 · standardAP
2024-04-03Labeling · Supplement 35 · standardAP
2024-04-03Labeling · Supplement 33 · standardAP
2024-04-03Labeling · Supplement 30 · standardAP
2017-06-30Labeling · Supplement 24 · standardAP
2015-06-14Labeling · Supplement 21 · standardAP
2015-06-14Labeling · Supplement 16 · standardAP
2015-06-14Labeling · Supplement 20 · standardAP
2013-08-16Labeling · Supplement 12 · standardAP
2012-04-18Labeling · Supplement 11AP
2010-04-27REMS · Supplement 8AP
2009-11-16Labeling · Supplement 5AP
2009-03-24OriginalAP
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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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