APPLICATION
ANDA210081
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-03
LATEST ACTION
2025-01-22
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
2025-01-22Labeling · Supplement 19 · standardAP
2023-02-07Labeling · Supplement 16 · standardAP
2023-02-07Labeling · Supplement 11 · standardAP
2017-11-03UNKNOWN · Original · 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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