APPLICATION
ANDA077284
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-14
LATEST ACTION
2023-08-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-08-02Labeling · Supplement 47 · standardAP
2023-08-02Labeling · Supplement 54 · standardAP
2023-08-02Labeling · Supplement 52 · standardAP
2019-06-12Labeling · Supplement 42 · standardAP
2017-08-25Labeling · Supplement 39 · standardAP
2017-08-25Labeling · Supplement 33 · standardAP
2017-08-25Labeling · Supplement 36 · standardAP
2014-12-13Labeling · Supplement 30 · standardAP
2011-10-31Labeling · Supplement 23AP
2011-08-30Labeling · Supplement 22AP
2011-01-25Labeling · Supplement 18AP
2011-01-20Labeling · Supplement 11AP
2010-11-19REMS · Supplement 20AP
2009-12-15Labeling · Supplement 17AP
2007-09-17Labeling · Supplement 8AP
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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