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FDA ANDA · ANDA206674
BUPROPION HYDROCHLORIDE (SR)
bupropion hydrochloride
Sponsor: INVAGEN PHARMS
APPLICATION
ANDA206674
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-09
LATEST ACTION
2021-01-04
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
2021-01-04Labeling · Supplement 10 · standardAP
2021-01-04Labeling · Supplement 5 · standardAP
2021-01-04Labeling · Supplement 13 · standardAP
2017-04-17Labeling · Supplement 1 · standardAP
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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