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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Daiichi Sankyo

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200647

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NDA 200647 describes FLUDARABINE PHOSPHATE, which is a drug marketed by Actavis Llc, Actavis Totowa, Custopharm Inc, Fresenius Kabi Usa, Hospira, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, and Sandoz, and is included in eleven NDAs. It is available from nine suppliers. Additional details are available on the FLUDARABINE PHOSPHATE profile page.

The generic ingredient in FLUDARABINE PHOSPHATE is fludarabine phosphate. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.
Summary for 200647
Applicant:Mylan Labs Ltd
Ingredient:fludarabine phosphate
Formulation / Manufacturing:see details
Pharmacology for NDA: 200647
Suppliers and Packaging for NDA: 200647
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 200647 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-9321 0069-9321-22 2 mL in 1 VIAL (0069-9321-22)
FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 200647 ANDA Mylan Institutional LLC 67457-495 67457-495-21 1 VIAL in 1 CARTON (67457-495-21) > 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/2ML (25MG/ML)
Approval Date:Dec 21, 2011TE:APRLD:No

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Queensland Health
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Harvard Business School
Express Scripts

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