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Last Updated: August 9, 2020

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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 one supplier. Additional details are available on the PRILOCAINE HYDROCHLORIDE profile page.

The generic ingredient in PRILOCAINE HYDROCHLORIDE is epinephrine bitartrate; prilocaine hydrochloride. There are twenty-one drug master file entries for this compound. One supplier is 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
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 Dentsply Pharmaceutical Inc. 66312-630 66312-630-14 50 CARTRIDGE in 1 CARTON (66312-630-14) > 1.8 mL in 1 CARTRIDGE

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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