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Details for New Drug Application (NDA): 078639

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NDA 078639 describes FOMEPIZOLE, which is a drug marketed by Mylan Institutional, Navinta Llc, and Luitpold, 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 NDA: 078639

Mylan Institutional
Formulation / Manufacturing:see details

Pharmacology for NDA: 078639

Suppliers and Packaging for NDA: 078639

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 078639 ANDA Mylan Institutional LLC 67457-211 67457-211-02 1 VIAL, GLASS in 1 CARTON (67457-211-02) > 1.5 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.5GM/1.5ML (1GM/ML)
Approval Date:Mar 3, 2008TE:APRLD:No

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