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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078393

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NDA 078393 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 078393

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078393

Suppliers and Packaging for NDA: 078393

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 078393 ANDA Fresenius Kabi USA, LLC 63323-192 63323-192-02 1 VIAL in 1 BOX (63323-192-02) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/2ML (25MG/ML)
Approval Date:Oct 15, 2007TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

US Army
US Department of Justice
Medtronic
Novartis
Cerilliant
Accenture
Chubb
Farmers Insurance
Citi
Daiichi Sankyo

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