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FDA Approval

VARDENAFIL HYDROCHLORIDE

CompanyAlembic Pharmaceuticals Inc. (DUNS: 079288842)

Effective Date

March 22, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Vardenafil Hydrochloride(2.5 mg in 1 1)

Manufacturing Establishments (1)

Alembic Pharmaceuticals Limited

Labeler

Alembic Pharmaceuticals Inc.

DUNS Number

650574671

Products (4)

VARDENAFIL HYDROCHLORIDE

NDC Product Code

62332-236

Application Number

ANDA214031

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 22, 2023

Ingredients

Vardenafil HydrochlorideActive

Code: 5M8S2CU0TSClass: ACTIMQuantity: 2.5 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1MClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

VARDENAFIL HYDROCHLORIDE

NDC Product Code

62332-237

Application Number

ANDA214031

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 22, 2023

Ingredients

Vardenafil HydrochlorideActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1MClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

VARDENAFIL HYDROCHLORIDE

NDC Product Code

62332-239

Application Number

ANDA214031

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 22, 2023

Ingredients

Vardenafil HydrochlorideActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1MClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

VARDENAFIL HYDROCHLORIDE

NDC Product Code

62332-238

Application Number

ANDA214031

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 22, 2023

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Vardenafil HydrochlorideActive

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

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1MClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

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