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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022137

FLUDARABINE PHOSPHATE (FLUDARABINE PHOSPHATE)
50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUDARABINE PHOSPHATE
Proprietary Name: FLUDARABINE PHOSPHATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022137
Product Number: 001
Approval Date: Sep 21, 2007
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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