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RAPAFLO

RAPAFLO® (silodosin) Capsules These highlights do not include all the information needed to use RAPAFLO® safely and effectively. See full prescribing information for RAPAFLO. RAPAFLO® (silodosin) capsule for oral useInitial U.S. Approval: 2008

Approved
Approval ID

96425d91-cfe1-477d-a130-b58c330ca8a3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 15, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

silodosin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-6173
Application NumberNDA022206
Product Classification
M
Marketing Category
C73594
G
Generic Name
silodosin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2012
FDA Product Classification

INGREDIENTS (1)

SILODOSINActive
Quantity: 8 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIM

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RAPAFLO - FDA Drug Approval Details