MedPath
FDA Approval

Vardenafil Hydrochloride

January 10, 2024

HUMAN PRESCRIPTION DRUG LABEL

Products (2)

Vardenafil Hydrochloride

42291-847

ANDA209057

ANDA (C73584)

ORAL

January 10, 2024

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Code: 5M8S2CU0TSClass: ACTIMQuantity: 10 mg in 1 1

Vardenafil Hydrochloride

42291-848

ANDA209057

ANDA (C73584)

ORAL

January 10, 2024

Code: 5M8S2CU0TSClass: ACTIMQuantity: 20 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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