APPLICATION
ANDA207389
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-18
LATEST ACTION
2025-11-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 75MG · TABLET · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2025-11-06Labeling · Supplement 9 · standardAP
2024-05-07Labeling · Supplement 8 · standardAP
2023-02-08Labeling · Supplement 6 · standardAP
2023-02-08Labeling · Supplement 7 · standardAP
2020-10-29Labeling · Supplement 5 · standardAP
2017-09-18UNKNOWN · 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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