Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209080

Marketing Status: Prescription
Active Ingredient: RILUZOLE
Proprietary Name: TIGLUTIK KIT
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 50MG/10ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209080
Product Number: 001
Approval Date: Sep 5, 2018
Applicant Holder Full Name: ITALFARMACO SPA
Marketing Status:  Prescription
Patent and Exclusivity Information

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