APPLICATION
ANDA202775
TYPE
ANDA
ORIGINAL APPROVAL
2013-10-11
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-11-05Labeling · Supplement 16 · standardAP
2024-05-07Labeling · Supplement 15 · standardAP
2024-04-10Labeling · Supplement 6 · standardAP
2024-04-10Labeling · Supplement 14 · standardAP
2015-06-14Labeling · Supplement 5 · standardAP
2015-06-14Labeling · Supplement 4 · standardAP
2013-10-11UNKNOWN · 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.
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.