APPLICATION
ANDA077475
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-12
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 22 · standardAP
2024-05-07Labeling · Supplement 21 · standardAP
2021-08-18Labeling · Supplement 20 · standardAP
2017-06-30Labeling · Supplement 18 · standardAP
2017-06-30Labeling · Supplement 19 · standardAP
2015-11-10Labeling · Supplement 16 · standardAP
2015-11-10Labeling · Supplement 17 · standardAP
2013-08-16Labeling · Supplement 14 · standardAP
2012-02-09Labeling · Supplement 12AP
2011-11-22Labeling · Supplement 9AP
2010-06-25REMS · Supplement 7AP
2010-01-25Labeling · Supplement 5AP
2008-09-23Labeling · Supplement 1AP
2008-03-12OriginalAP
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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