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FDA Approval

Vardenafil Hydrochloride

CompanyTeva Pharmaceuticals USA, Inc. (DUNS: 001627975)

Effective Date

December 8, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Vardenafil Hydrochloride(20 mg in 1 1)

Products (4)

Vardenafil Hydrochloride

NDC Product Code

0093-7655

Application Number

ANDA091347

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2023

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Vardenafil HydrochlorideActive

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TARTARIC ACIDInactive

Code: W4888I119HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Vardenafil Hydrochloride

NDC Product Code

0093-7653

Application Number

ANDA091347

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2023

Ingredients

Vardenafil HydrochlorideActive

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

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TARTARIC ACIDInactive

Code: W4888I119HClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Vardenafil Hydrochloride

NDC Product Code

0093-7654

Application Number

ANDA091347

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2023

Ingredients

Vardenafil HydrochlorideActive

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TARTARIC ACIDInactive

Code: W4888I119HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Vardenafil Hydrochloride

NDC Product Code

0093-7652

Application Number

ANDA091347

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2023

Ingredients

Vardenafil HydrochlorideActive

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

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TARTARIC ACIDInactive

Code: W4888I119HClass: IACT

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