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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209401

VYXEOS (CYTARABINE; DAUNORUBICIN)
100MG;44MG
Marketing Status: Prescription
Active Ingredient: CYTARABINE; DAUNORUBICIN
Proprietary Name: VYXEOS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 100MG;44MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209401
Product Number: 001
Approval Date: Aug 3, 2017
Applicant Holder Full Name: CELATOR PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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