Details for New Drug Application (NDA): 022137
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The generic ingredient in FLUDARABINE PHOSPHATE is fludarabine phosphate. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.
Summary for 022137
Tradename: | FLUDARABINE PHOSPHATE |
Applicant: | Sandoz |
Ingredient: | fludarabine phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 21, 2007 | TE: | RLD: | Yes |
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