APPLICATION
ANDA210626
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-10
LATEST ACTION
2021-07-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
SILODOSINPrescription
SILODOSIN 8MG · CAPSULE · ORAL
SILODOSINPrescription
SILODOSIN 4MG · CAPSULE · ORAL
Approval history
2021-07-02Labeling · Supplement 3 · standardAP
2018-12-10UNKNOWN · 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.