Litfulo
These highlights do not include all the information needed to use LITFULO safely and effectively. See full prescribing information for LITFULO. LITFULO™ (ritlecitinib) capsules, for oral use Initial U.S. Approval: 2023
Approved
Approval ID
1882f799-61b0-4813-965a-4910c4ae419c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 23, 2023
Manufacturers
FDA
U.S. Pharmaceuticals
DUNS: 829076905
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ritlecitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-334
Application NumberNDA215830
Product Classification
M
Marketing Category
C73594
G
Generic Name
ritlecitinib
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2023
FDA Product Classification
INGREDIENTS (9)
RITLECITINIB TOSYLATEActive
Quantity: 50 mg in 1 1
Code: EAG4T1459K
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT