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FDA ANDA · ANDA203969

BUPROPION HYDROCHLORIDE

Sponsor: TORRENT

APPLICATION
ANDA203969
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-31
LATEST ACTION
2021-03-01
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

2021-03-01Labeling · Supplement 4 · standardAP
2021-03-01Labeling · Supplement 2 · standardAP
2014-10-31UNKNOWN · OriginalAP
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