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US Army
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Moodys
Federal Trade Commission
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Baxter
Merck
Mallinckrodt
Express Scripts

Generated: July 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078368

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NDA 078368 describes FOMEPIZOLE, which is a drug marketed by Luitpold, Mylan Institutional, and Navinta Llc, and is included in four NDAs. It is available from three suppliers. Additional details are available on the FOMEPIZOLE profile page.

The generic ingredient in FOMEPIZOLE is fomepizole. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fomepizole profile page.
Summary for 078368
Tradename:FOMEPIZOLE
Applicant:Luitpold
Ingredient:fomepizole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078368
Suppliers and Packaging for NDA: 078368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078368 ANDA X-GEN Pharmaceuticals 39822-0710 N 39822-0710-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.5GM/1.5ML (1GM/ML)
Approval Date:Dec 14, 2007TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Citi
Cerilliant
QuintilesIMS
AstraZeneca
Accenture
Healthtrust
McKesson
UBS

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