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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
McKesson
Argus Health
Federal Trade Commission
Cantor Fitzgerald
UBS
Boehringer Ingelheim
Harvard Business School
McKinsey

Generated: June 25, 2018

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 two suppliers. 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 078959
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 E 0362-9013-50
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 078959 ANDA Dentsply Pharmaceutical Inc. 66312-580 N 66312-580-16

Profile 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 hundreds of leading biopharmaceutical companies globally:

Deloitte
Chinese Patent Office
Fish and Richardson
Julphar
Cipla
Daiichi Sankyo
Accenture
QuintilesIMS
Merck

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