VEOZAH

Registrants (1)

Astellas Pharma US, Inc.

DUNS Number

605764828

Manufacturing Establishments (4)

AndersonBrecon Inc.

Labeler

Astellas Pharma US, Inc.

Registrant

Astellas Pharma US, Inc.

DUNS Number

053217022

Fujimoto Chemicals Co., Ltd.

Labeler

Astellas Pharma US, Inc.

Registrant

Astellas Pharma US, Inc.

DUNS Number

717836709

Astellas Pharma Inc.

Labeler

Astellas Pharma US, Inc.

Registrant

Astellas Pharma US, Inc.

DUNS Number

695086702

Juzen Chemical Corporation

Labeler

Astellas Pharma US, Inc.

Registrant

Astellas Pharma US, Inc.

DUNS Number

691036974

Products (3)

NDC Product Code

0469-2760

Application Number

NDA216578

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

May 19, 2023

Ingredients

FezolinetantActive

Code: 83VNE45KXXClass: ACTIBQuantity: 45 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

VEOZAH

NDC Product Code

0469-2660

Application Number

NDA216578

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

May 19, 2023

Ingredients

FezolinetantActive

Code: 83VNE45KXXClass: ACTIBQuantity: 45 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

VEOZAH

NDC Product Code

0469-2460

Application Number

NDA216578

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

May 19, 2023

Ingredients

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

FezolinetantActive

Code: 83VNE45KXXClass: ACTIBQuantity: 45 mg in 1 1

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

AI-Powered Research

Premium Access

VEOZAH

Registrants (1)

Manufacturing Establishments (4)

Products (3)

VEOZAH

VEOZAH

VEOZAH