teriflunomide
These highlights do not include all the information needed to use TERIFLUNOMIDE TABLETS safely and effectively. See full prescribing information for TERIFLUNOMIDE TABLETS. Teriflunomide tablets, for oral use Initial U.S. Approval: 2012
Approved
Approval ID
8e6d1915-686c-4a57-af8a-c5ba61746821
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
SOLA Pharmaceuticals, LLC
DUNS: 080121345
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
teriflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70512-850
Application NumberANDA209677
Product Classification
M
Marketing Category
C73584
G
Generic Name
teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2023
FDA Product Classification
INGREDIENTS (12)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TERIFLUNOMIDEActive
Quantity: 7 mg in 1 1
Code: 1C058IKG3B
Classification: ACTIB
teriflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70512-851
Application NumberANDA209677
Product Classification
M
Marketing Category
C73584
G
Generic Name
teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2023
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TERIFLUNOMIDEActive
Quantity: 14 mg in 1 1
Code: 1C058IKG3B
Classification: ACTIB