APPLICATION
ANDA091459
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-09
LATEST ACTION
2023-12-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-12-05Labeling · Supplement 12 · standardAP
2023-12-05Labeling · Supplement 10 · standardAP
2023-12-05Labeling · Supplement 13 · standardAP
2023-12-05Labeling · Supplement 11 · standardAP
2017-04-28Labeling · Supplement 9 · standardAP
2014-11-20Labeling · Supplement 8 · standardAP
2013-01-31Labeling · Supplement 2AP
2011-06-09OriginalAP
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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