Sildenafil Citrate
These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
a3752548-1472-48b6-9998-119f8a9ecb8d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 2, 2018
Manufacturers
FDA
Vensun Pharmaceuticals, Inc.
DUNS: 078310501
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sildenafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42543-005
Application NumberANDA204883
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2016
FDA Product Classification
INGREDIENTS (9)
SILDENAFIL CITRATEActive
Quantity: 20 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT