BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Express Scripts
Argus Health

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020696

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NDA 020696 describes ANTIZOL, which is a drug marketed by Par Pharm Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ANTIZOL profile page.

The generic ingredient in ANTIZOL 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 020696

Formulation / Manufacturing:see details

Pharmacology for NDA: 020696

Suppliers and Packaging for NDA: 020696

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANTIZOL fomepizole INJECTABLE;INJECTION 020696 NDA PALADIN LABORATORIES (USA) INC 46129-200 46129-200-01 1 VIAL in 1 PACKAGE (46129-200-01) > 1.5 mL in 1 VIAL
ANTIZOL fomepizole INJECTABLE;INJECTION 020696 NDA PALADIN LABORATORIES (USA) INC 46129-200 46129-200-02 4 VIAL in 1 PACKAGE (46129-200-02) > 1.5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.5GM/1.5ML (1GM/ML)
Approval Date:Dec 4, 1997TE:APRLD:Yes
Patent:► SubscribePatent Expiration:Jun 30, 2027Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Daiichi Sankyo
Queensland Health
Express Scripts

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