APPLICATION
ANDA076834
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-14
LATEST ACTION
2025-11-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-11-06Labeling · Supplement 17 · standardAP
2024-05-07Labeling · Supplement 16 · standardAP
2024-04-15Labeling · Supplement 15 · standardAP
2008-01-16Labeling · Supplement 7AP
2008-01-16Labeling · Supplement 10AP
2007-02-09Labeling · Supplement 4AP
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.