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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Chinese Patent Office
Express Scripts

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090724

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NDA 090724 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 090724
Applicant:Mustafa Nevzat Ilac
Ingredient:fludarabine phosphate
Formulation / Manufacturing:see details
Pharmacology for NDA: 090724
Suppliers and Packaging for NDA: 090724
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 090724 ANDA Mylan Institutional LLC 67457-238 67457-238-02 1 VIAL, GLASS in 1 CARTON (67457-238-02) > 2 mL in 1 VIAL, GLASS
FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 090724 ANDA Mylan Institutional LLC 67457-268 67457-268-02 1 VIAL, GLASS in 1 CARTON (67457-268-02) > 2 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/2ML (25MG/ML)
Approval Date:Sep 27, 2010TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Argus Health
Federal Trade Commission
US Department of Justice

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