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
36a961f1-d0a6-437b-a9ea-54735e4cd1e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2020
Manufacturers
FDA
MSN LABORATORIES PRIVATE LIMITED
DUNS: 650786952
Products 2
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 Code69539-053
Application NumberANDA210687
Product Classification
M
Marketing Category
C73584
G
Generic Name
SILODOSIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2020
FDA Product Classification
INGREDIENTS (12)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILODOSINActive
Quantity: 8 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM ALUMINOMETASILICATE TYPE IAInactive
Code: 7LVU907546
Classification: IACT
SILODOSIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69539-052
Application NumberANDA210687
Product Classification
M
Marketing Category
C73584
G
Generic Name
SILODOSIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2020
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILODOSINActive
Quantity: 4 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM ALUMINOMETASILICATE TYPE IAInactive
Code: 7LVU907546
Classification: IACT