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FDA Approval

Teriflunomide

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
AvKARE
DUNS: 796560394
Effective Date
May 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Teriflunomide(7 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Teriflunomide

Product Details

NDC Product Code
42291-830
Application Number
ANDA209700
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2023
Code: 1C058IKG3BClass: ACTIBQuantity: 7 mg in 1 1

Teriflunomide

Product Details

NDC Product Code
42291-831
Application Number
ANDA209700
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2023
Code: 1C058IKG3BClass: ACTIBQuantity: 14 mg in 1 1
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