APPLICATION
ANDA203013
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-08
LATEST ACTION
2025-11-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 75MG · TABLET · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2025-11-06Labeling · Supplement 20 · standardAP
2025-01-29Labeling · Supplement 17 · standardAP
2024-05-07Labeling · Supplement 15 · standardAP
2023-10-03Labeling · Supplement 13 · standardAP
2023-10-03Labeling · Supplement 6 · standardAP
2023-10-03Labeling · Supplement 12 · standardAP
2018-06-08UNKNOWN · 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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