Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202992

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AUBAGIO (TERIFLUNOMIDE)
7MG
Marketing Status: Prescription

Active Ingredient: TERIFLUNOMIDE
Proprietary Name: AUBAGIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202992
Product Number: 001
Approval Date: Sep 12, 2012
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AUBAGIO (TERIFLUNOMIDE)
14MG
Marketing Status: Prescription

Active Ingredient: TERIFLUNOMIDE
Proprietary Name: AUBAGIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 14MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202992
Product Number: 002
Approval Date: Sep 12, 2012
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information