Silodosin
These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
b9880aad-5fbe-470b-a7a0-d963ba4bc98b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2020
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Silodosin
PRODUCT DETAILS
NDC Product Code31722-635
Application NumberANDA204793
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 25, 2020
Generic NameSilodosin
INGREDIENTS (14)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SILODOSINActive
Quantity: 4 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Silodosin
PRODUCT DETAILS
NDC Product Code31722-636
Application NumberANDA204793
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 25, 2020
Generic NameSilodosin
INGREDIENTS (14)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILODOSINActive
Quantity: 8 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT