APPLICATION
ANDA211166
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-03
LATEST ACTION
2021-07-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
SILODOSINPrescription
SILODOSIN 8MG · CAPSULE · ORAL
SILODOSINPrescription
SILODOSIN 4MG · CAPSULE · ORAL
Approval history
2021-07-16Labeling · Supplement 8 · standardAP
2018-12-03UNKNOWN · 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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