APPLICATION
ANDA204793
TYPE
ANDA
ORIGINAL APPROVAL
2020-02-14
LATEST ACTION
2024-08-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
SILODOSINPrescription
SILODOSIN 4MG · CAPSULE · ORAL
SILODOSINPrescription
SILODOSIN 8MG · CAPSULE · ORAL
Approval history
2024-08-16Labeling · Supplement 1 · standardAP
2020-02-14UNKNOWN · 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.
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