APPLICATION
ANDA207403
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-17
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 100MG · TABLET · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 75MG · TABLET · ORAL
Approval history
2025-11-05Labeling · Supplement 7 · standardAP
2025-10-06Labeling · Supplement 6 · standardAP
2025-03-14Labeling · Supplement 5 · standardAP
2024-05-07Labeling · Supplement 4 · standardAP
2024-04-15Labeling · Supplement 3 · standardAP
2024-04-15Labeling · Supplement 2 · standardAP
2020-04-17UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.