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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 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 seventeen 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 NDA: 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

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 0362-9014-50 50 CARTRIDGE in 1 CARTON (0362-9014-50) > 1.8 mL in 1 CARTRIDGE
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4%
Approval Date:Sep 29, 2010TE:RLD:Yes


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