APPLICATION
ANDA090942
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-14
LATEST ACTION
2017-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2017-06-12Labeling · Supplement 13 · standardAP
2017-06-12Labeling · Supplement 12 · standardAP
2014-12-19Labeling · Supplement 10 · standardAP
2013-04-26Labeling · Supplement 8 · standardAP
2010-07-14OriginalAP
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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