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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205582

DECITABINE (DECITABINE)
50MG/VIAL
Marketing Status: Prescription
Active Ingredient: DECITABINE
Proprietary Name: DECITABINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 50MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205582
Product Number: 001
Approval Date: Jan 28, 2014
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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