Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
Queensland Health
Moodys
McKinsey
Chubb
Fish and Richardson
Mallinckrodt
Accenture

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079235

« Back to Dashboard

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
Tradename:PRILOCAINE HYDROCHLORIDE
Applicant:Septodont Inc
Ingredient:prilocaine hydrochloride
Patents:0
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079235
Ingredient-typeAmides
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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Cipla
Baxter
Express Scripts
Deloitte
Accenture
Chubb
Farmers Insurance

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.