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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208114

DEFITELIO (DEFIBROTIDE SODIUM)
200MG/2.5ML (80MG/ML)
Marketing Status: Prescription
Active Ingredient: DEFIBROTIDE SODIUM
Proprietary Name: DEFITELIO
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200MG/2.5ML (80MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208114
Product Number: 001
Approval Date: Mar 30, 2016
Applicant Holder Full Name: JAZZ PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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