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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076661

FLUDARABINE PHOSPHATE (FLUDARABINE PHOSPHATE)
50MG/2ML (25MG/ML)
Marketing Status: Prescription
Active Ingredient: FLUDARABINE PHOSPHATE
Proprietary Name: FLUDARABINE PHOSPHATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/2ML (25MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP1
Application Number: A076661
Product Number: 001
Approval Date: Apr 28, 2004
Applicant Holder Full Name: SAGENT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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