APPLICATION
ANDA090377
TYPE
ANDA
ORIGINAL APPROVAL
2010-03-02
LATEST ACTION
2023-07-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TAMSULOSIN HYDROCHLORIDEPrescription
TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL
Approval history
2023-07-25Labeling · Supplement 11 · standardAP
2011-10-31Labeling · Supplement 3AP
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.