APPLICATION
ANDA076143
TYPE
ANDA
ORIGINAL APPROVAL
2006-01-17
LATEST ACTION
2025-11-05
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
2025-11-05Labeling · Supplement 39 · standardAP
2025-10-06Labeling · Supplement 36 · standardAP
2024-08-22Labeling · Supplement 34 · standardAP
2024-05-07Labeling · Supplement 33 · standardAP
2023-10-10Labeling · Supplement 29 · standardAP
2022-08-22Labeling · Supplement 19 · standardAP
2022-08-22Labeling · Supplement 25 · standardAP
2022-08-22Labeling · Supplement 17 · standardAP
2022-08-22Labeling · Supplement 23 · standardAP
2022-08-22Labeling · Supplement 21 · standardAP
2022-08-22Labeling · Supplement 26 · standardAP
2022-08-22Labeling · Supplement 18 · standardAP
2014-11-20Labeling · Supplement 11 · standardAP
2014-11-20Labeling · Supplement 16 · standardAP
2014-11-20Labeling · Supplement 12 · standardAP
2012-04-16Labeling · Supplement 10AP
2011-01-21Labeling · Supplement 9AP
2010-07-08REMS · Supplement 8AP
2010-01-22Labeling · Supplement 6AP
2009-07-01Labeling · Supplement 4AP
2008-01-15Labeling · Supplement 2AP
2006-10-05Labeling · Supplement 1AP
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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