SOTYKTU
These highlights do not include all the information needed to use SOTYKTU safely and effectively. See full prescribing information for SOTYKTU. SOTYKTU™ (deucravacitinib) tablets, for oral useInitial U.S. Approval: 2022
Approved
Approval ID
ff4d7258-5068-4cdf-9692-8cae04c3198e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2022
Manufacturers
FDA
E.R. Squibb & Sons, L.L.C.
DUNS: 011550092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
deucravacitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-0895
Application NumberNDA214958
Product Classification
M
Marketing Category
C73594
G
Generic Name
deucravacitinib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2022
FDA Product Classification
INGREDIENTS (13)
DEUCRAVACITINIBActive
Quantity: 6 mg in 1 1
Code: N0A21N6RAU
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT