Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209613

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TERIFLUNOMIDE (TERIFLUNOMIDE)
7MG
Marketing Status: Discontinued
Active Ingredient: TERIFLUNOMIDE
Proprietary Name: TERIFLUNOMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209613
Product Number: 001
Approval Date: Sep 28, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status:  Discontinued
Patent and Exclusivity Information
TERIFLUNOMIDE (TERIFLUNOMIDE)
14MG
Marketing Status: Discontinued
Active Ingredient: TERIFLUNOMIDE
Proprietary Name: TERIFLUNOMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 14MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209613
Product Number: 002
Approval Date: Sep 28, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status:  Discontinued
Patent and Exclusivity Information

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