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FDA Approval

Vardenafil hydrochloride

CompanyAmneal Pharmaceuticals NY LLC (DUNS: 123797875)

Effective Date

September 30, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Vardenafil Hydrochloride(20 mg in 1 1)

Products (3)

Vardenafil hydrochloride

NDC Product Code

69238-1153

Application Number

ANDA210738

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 30, 2023

Ingredients

TALCInactive

Code: 7SEV7J4R1UClass: IACT

Vardenafil HydrochlorideActive

Code: 5M8S2CU0TSClass: ACTIMQuantity: 20 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Vardenafil hydrochloride

NDC Product Code

69238-1152

Application Number

ANDA210738

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 30, 2023

Ingredients

Vardenafil HydrochlorideActive

Code: 5M8S2CU0TSClass: ACTIMQuantity: 10 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Vardenafil hydrochloride

NDC Product Code

69238-1151

Application Number

ANDA210738

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 30, 2023

Ingredients

Vardenafil HydrochlorideActive

Code: 5M8S2CU0TSClass: ACTIMQuantity: 5 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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