APPLICATION
ANDA075584
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-07
LATEST ACTION
2026-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 100MG · TABLET · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 75MG · TABLET · ORAL
Approval history
2026-02-25Labeling · Supplement 61 · standardAP
2024-05-07Labeling · Supplement 60 · standardAP
2023-10-10Labeling · Supplement 56 · standardAP
2023-10-10Labeling · Supplement 48 · standardAP
2023-10-10Labeling · Supplement 54 · standardAP
2023-10-10Labeling · Supplement 46 · standardAP
2015-05-16Labeling · Supplement 42 · standardAP
2015-05-16Labeling · Supplement 41 · standardAP
2014-09-24Labeling · Supplement 38 · standardAP
2014-09-24Labeling · Supplement 36 · standardAP
2012-03-28Labeling · Supplement 34AP
2012-03-27Labeling · Supplement 33AP
2010-07-08REMS · Supplement 32AP
2010-03-04Labeling · Supplement 31AP
2009-11-16Labeling · Supplement 27AP
2008-12-19Labeling · Supplement 23AP
2008-01-16Labeling · Supplement 20AP
2007-12-19Labeling · Supplement 24AP
2007-02-08Labeling · Supplement 14AP
2007-02-08Labeling · Supplement 19AP
2005-06-01Labeling · Supplement 12AP
2004-02-04Labeling · Supplement 9AP
2002-11-05Labeling · Supplement 7AP
2002-01-18Manufacturing (CMC) · Supplement 3AP
2002-01-18Manufacturing (CMC) · 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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