APPLICATION
ANDA090408
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-27
LATEST ACTION
2025-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TAMSULOSIN HYDROCHLORIDEDiscontinued
TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL
Approval history
2025-09-30Labeling · Supplement 14 · standardAP
2015-10-06Labeling · Supplement 10 · standardAP
2015-10-06Labeling · Supplement 7 · standardAP
2015-10-06Labeling · Supplement 11 · standardAP
2012-01-20Labeling · Supplement 5AP
2011-03-28Manufacturing (CMC) · Supplement 1AP
2010-04-27OriginalAP
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.