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Details for New Drug Application (NDA): 020696

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NDA 020696 describes ANTIZOL, which is a drug marketed by Paladin Labs 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 NDA: 020696

Paladin Labs
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
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
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:7,553,863Patent Expiration:Jun 30, 2027Product Flag?YSubstance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.