Teriflunomide
Teriflunomide Tablets Rx only These highlights do not include all the information needed to use TERIFLUNOMIDE TABLETS safely and effectively. See full prescribing information for TERIFLUNOMIDE TABLETS. Initial U.S. Approval: 2012
Approved
Approval ID
f9c95ed7-130f-9455-e053-6394a90a182f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2023
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-830
Application NumberANDA209700
Product Classification
M
Marketing Category
C73584
G
Generic Name
Teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (1)
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 Code42291-831
Application NumberANDA209700
Product Classification
M
Marketing Category
C73584
G
Generic Name
Teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (1)
TERIFLUNOMIDEActive
Quantity: 14 mg in 1 1
Code: 1C058IKG3B
Classification: ACTIB