APPLICATION
ANDA201331
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-30
LATEST ACTION
2015-05-14
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
2015-05-14Labeling · Supplement 2 · standardAP
2014-07-18Manufacturing (CMC) · Supplement 1 · unknownAP
2012-08-30Not Applicable · OriginalAP
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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