APPLICATION
ANDA208606
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-16
LATEST ACTION
2025-11-05
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
2025-11-05Labeling · Supplement 5 · standardAP
2024-05-07Labeling · Supplement 3 · standardAP
2023-02-07Labeling · Supplement 1 · standardAP
2023-02-07Labeling · Supplement 2 · standardAP
2020-01-16UNKNOWN · 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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