NITYR
These highlights do not include all the information needed to use NITYR safely and effectively. See full prescribing information for NITYR. NITYR(nitisinone) tablets, for oral useInitial U.S. Approval: 2002
Approved
Approval ID
00fd1905-27e4-420e-8dc5-a69e4ddc1526
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2024
Manufacturers
FDA
Cycle Pharmaceuticals Ltd.
DUNS: 218215530
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nitisinone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70709-000
Application NumberNDA209449
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitisinone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2018
FDA Product Classification
INGREDIENTS (3)
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
nitisinoneActive
Quantity: 10 mg in 1 1
Code: K5BN214699
Classification: ACTIB
Nitisinone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70709-002
Application NumberNDA209449
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitisinone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2018
FDA Product Classification
INGREDIENTS (3)
nitisinoneActive
Quantity: 2 mg in 1 1
Code: K5BN214699
Classification: ACTIB
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Nitisinone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70709-005
Application NumberNDA209449
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitisinone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2018
FDA Product Classification
INGREDIENTS (3)
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
nitisinoneActive
Quantity: 5 mg in 1 1
Code: K5BN214699
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT