APPLICATION
ANDA090941
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-03
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-11-05Labeling · Supplement 17 · standardAP
2024-05-07Labeling · Supplement 16 · standardAP
2024-04-16Labeling · Supplement 15 · standardAP
2024-04-16Labeling · Supplement 13 · standardAP
2017-04-28Labeling · Supplement 10 · standardAP
2017-04-28Labeling · Supplement 9 · standardAP
2014-11-20Labeling · Supplement 6 · standardAP
2014-11-20Labeling · Supplement 7 · standardAP
2010-05-03OriginalAP
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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