APPLICATION
ANDA075932
TYPE
ANDA
ORIGINAL APPROVAL
2003-11-25
LATEST ACTION
2025-03-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-03-18Labeling · Supplement 51 · standardAP
2022-09-02Labeling · Supplement 49 · standardAP
2021-01-11Labeling · Supplement 46 · standardAP
2021-01-11Labeling · Supplement 47 · standardAP
2021-01-11Labeling · Supplement 43 · standardAP
2016-07-15Labeling · Supplement 38 · standardAP
2016-07-15Labeling · Supplement 40 · standardAP
2016-07-15Labeling · Supplement 35 · standardAP
2014-11-20Labeling · Supplement 34 · standardAP
2014-11-20Labeling · Supplement 33 · standardAP
2012-04-18Labeling · Supplement 31AP
2010-10-25Labeling · Supplement 30AP
2010-09-08Labeling · Supplement 29AP
2010-04-05Labeling · Supplement 27AP
2009-11-05Labeling · Supplement 26AP
2008-10-31Labeling · Supplement 24AP
2008-02-05Labeling · Supplement 21AP
2007-06-04Labeling · Supplement 20AP
2006-11-06Labeling · Supplement 18AP
2005-08-01Labeling · Supplement 15AP
2005-06-22Labeling · Supplement 5AP
2005-06-22Supplement · Supplement 12AP
2005-06-22Supplement · Supplement 13AP
2005-06-22Supplement · Supplement 4AP
2004-11-18Labeling · Supplement 14AP
2004-11-18Labeling · Supplement 3AP
2004-11-18Labeling · Supplement 10AP
2004-04-28Labeling · Supplement 9AP
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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