APPLICATION
ANDA206975
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-19
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 35 · standardAP
2024-05-07Labeling · Supplement 30 · standardAP
2023-02-07Labeling · Supplement 21 · standardAP
2023-02-07Labeling · Supplement 16 · standardAP
2020-11-11Labeling · Supplement 4 · standardAP
2020-11-11Labeling · Supplement 3 · standardAP
2020-11-11Labeling · Supplement 12 · standardAP
2016-08-19UNKNOWN · 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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