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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Department of Justice
Fish and Richardson
Daiichi Sankyo
Chinese Patent Office

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079235

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NDA 079235 describes PRILOCAINE HYDROCHLORIDE, which is a drug marketed by Septodont Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the PRILOCAINE HYDROCHLORIDE profile page.

The generic ingredient in PRILOCAINE HYDROCHLORIDE is epinephrine bitartrate; prilocaine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the epinephrine bitartrate; prilocaine hydrochloride profile page.
Summary for 079235
Applicant:Septodont Inc
Ingredient:prilocaine hydrochloride
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079235
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 079235
Suppliers and Packaging for NDA: 079235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRILOCAINE HYDROCHLORIDE prilocaine hydrochloride INJECTABLE;INJECTION 079235 ANDA Septodont Inc. 0362-9014 E 0362-9014-50
PRILOCAINE HYDROCHLORIDE prilocaine hydrochloride INJECTABLE;INJECTION 079235 ANDA Dentsply Pharmaceutical Inc. 66312-630 N 66312-630-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4%
Approval Date:Sep 29, 2010TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo

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