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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Federal Trade Commission
Argus Health

Generated: December 14, 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 078959

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 leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Argus Health
Express Scripts
Federal Trade Commission

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