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
94bca72c-c74a-4181-8b6a-a0a2f654a0a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SILODOSIN
PRODUCT DETAILS
NDC Product Code72789-351
Application NumberANDA210626
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 22, 2023
Generic NameSILODOSIN
INGREDIENTS (12)
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILODOSINActive
Quantity: 4 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB