Vardenafil
These highlights do not include all the information needed to use VARDENAFIL ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for VARDENAFIL ORALLY DISINTEGRATING TABLETS. VARDENAFIL orally disintegrating tablets Initial U.S. Approval: 2003
Approved
Approval ID
0ad213e0-d18a-4e67-a405-df95322eaa52
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vardenafil
PRODUCT DETAILS
NDC Product Code33342-203
Application NumberANDA205988
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2023
Generic NameVardenafil
INGREDIENTS (9)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VARDENAFIL HYDROCHLORIDE TRIHYDRATEActive
Quantity: 11.85 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT