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Generated: October 23, 2018

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Details for New Drug Application (NDA): 078537

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NDA 078537 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 078537
Applicant:Navinta Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 078537
Suppliers and Packaging for NDA: 078537
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078537 ANDA Sandoz Inc. 0781-3182 0781-3182-84 4 CARTON in 1 CARTON (0781-3182-84) > 1 VIAL in 1 CARTON (0781-3182-73) > 1.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.5GM/1.5ML (1GM/ML)
Approval Date:Mar 6, 2008TE:APRLD:No

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