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Details for New Drug Application (NDA): 020038

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NDA 020038 describes FLUDARA, which is a drug marketed by Genzyme Corp, Actavis Totowa, Mustafa Nevzat Ilac, Sandoz, Fresenius Kabi Usa, Mylan Labs Ltd, Sagent Pharms, and Hospira, and is included in eleven NDAs. Additional details are available on the FLUDARA profile page.

The generic ingredient in FLUDARA is fludarabine phosphate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.

Summary for NDA: 020038

Genzyme Corp
fludarabine phosphate

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/VIAL
Approval Date:Apr 18, 1991TE:RLD:No

Expired Orange Book Patents for NDA: 020038

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme Corp
fludarabine phosphate
INJECTABLE;INJECTION020038-001Apr 18, 19914,357,324*PED<disabled>
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