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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050794

Marketing Status: Prescription
Active Ingredient: AZACITIDINE
Proprietary Name: VIDAZA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS, SUBCUTANEOUS
Strength: 100MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N050794
Product Number: 001
Approval Date: May 19, 2004
Applicant Holder Full Name: BRISTOL-MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information
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