VEOZAH
These highlights do not include all the information needed to use VEOZAH safely and effectively. See full prescribing information for VEOZAH. VEOZAH (fezolinetant) tablets, for oral useInitial U.S. Approval: 2023
Approved
Approval ID
cae9f798-24f9-4580-a4fc-e6c710cbda3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
Astellas Pharma US, Inc.
DUNS: 605764828
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fezolinetant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0469-2760
Application NumberNDA216578
Product Classification
M
Marketing Category
C73594
G
Generic Name
fezolinetant
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2023
FDA Product Classification
INGREDIENTS (11)
FEZOLINETANTActive
Quantity: 45 mg in 1 1
Code: 83VNE45KXX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
fezolinetant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0469-2660
Application NumberNDA216578
Product Classification
M
Marketing Category
C73594
G
Generic Name
fezolinetant
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2023
FDA Product Classification
INGREDIENTS (11)
FEZOLINETANTActive
Quantity: 45 mg in 1 1
Code: 83VNE45KXX
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
fezolinetant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0469-2460
Application NumberNDA216578
Product Classification
M
Marketing Category
C73594
G
Generic Name
fezolinetant
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2023
FDA Product Classification
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
FEZOLINETANTActive
Quantity: 45 mg in 1 1
Code: 83VNE45KXX
Classification: ACTIB
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT