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Serving 500+ biopharmaceutical companies globally:

Baxter
Colorcon
Chubb
Cipla
Queensland Health
AstraZeneca
Federal Trade Commission
Fish and Richardson
Merck
McKesson

Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078959

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NDA 078959 describes PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, which is a drug marketed by Septodont Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE profile page.

The generic ingredient in PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 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 NDA: 078959

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078959

Suppliers and Packaging for NDA: 078959

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
epinephrine bitartrate; prilocaine hydrochloride
INJECTABLE;INJECTION 078959 ANDA Septodont Inc. 0362-9013 0362-9013-50 50 CARTRIDGE in 1 CARTON (0362-9013-50) > 1.8 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.005MG/ML;4%
Approval Date:Aug 30, 2011TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Covington
US Army
Teva
Cerilliant
Novartis
McKinsey
Merck
Johnson and Johnson
Chubb

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