APPLICATION
ANDA075491
TYPE
ANDA
ORIGINAL APPROVAL
2000-04-17
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 75MG · TABLET · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2025-11-05Labeling · Supplement 44 · standardAP
2025-11-05Labeling · Supplement 43 · standardAP
2025-03-13Labeling · Supplement 42 · standardAP
2024-05-07Labeling · Supplement 40 · standardAP
2022-10-18Labeling · Supplement 38 · standardAP
2022-10-18Labeling · Supplement 36 · standardAP
2022-10-18Labeling · Supplement 37 · standardAP
2022-10-18Labeling · Supplement 35 · standardAP
2022-10-18Labeling · Supplement 33 · standardAP
2015-05-22Labeling · Supplement 31 · standardAP
2015-05-22Labeling · Supplement 30 · standardAP
2014-09-14Labeling · Supplement 28 · standardAP
2014-02-07Labeling · Supplement 26 · standardAP
2014-02-07Labeling · Supplement 27 · standardAP
2010-04-22REMS · Supplement 24AP
2009-12-10Labeling · Supplement 23AP
2009-01-26Labeling · Supplement 22AP
2008-09-08Labeling · Supplement 16AP
2008-01-16Labeling · Supplement 13AP
2008-01-16Labeling · Supplement 14AP
2007-05-01Labeling · Supplement 12AP
2006-02-06Labeling · Supplement 7AP
2005-04-08Labeling · Supplement 6AP
2004-02-06Labeling · Supplement 5AP
2002-08-26Labeling · Supplement 2AP
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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