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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214429

FEXINIDAZOLE (FEXINIDAZOLE)
600MG
Marketing Status: Prescription
Active Ingredient: FEXINIDAZOLE
Proprietary Name: FEXINIDAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214429
Product Number: 001
Approval Date: Jul 16, 2021
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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