APPLICATION
ANDA078866
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-06
LATEST ACTION
2024-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-11-26Labeling · Supplement 30 · standardAP
2024-11-26Labeling · Supplement 33 · standardAP
2023-06-21Labeling · Supplement 24 · standardAP
2023-06-21Labeling · Supplement 14 · standardAP
2023-06-21Labeling · Supplement 21 · standardAP
2023-06-21Labeling · Supplement 13 · standardAP
2017-04-14Labeling · Supplement 12 · standardAP
2017-04-14Labeling · Supplement 11 · standardAP
2014-11-20Labeling · Supplement 10 · standardAP
2014-11-20Labeling · Supplement 6 · standardAP
2013-07-28Labeling · Supplement 4 · standardAP
2010-04-06OriginalAP
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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