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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Johnson and Johnson
Farmers Insurance
Daiichi Sankyo

Generated: April 23, 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 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. One supplier is 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 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:

Chinese Patent Office
Daiichi Sankyo
US Army
Federal Trade Commission

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