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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077250

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NDA 077250 describes BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, which is a drug marketed by Hospira and Septodont and is included in eight NDAs. It is available from six suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE is bupivacaine hydrochloride; epinephrine bitartrate. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.

Summary for 077250

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

Pharmacology for NDA: 077250

Suppliers and Packaging for NDA: 077250

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 077250 ANDA Septodont, Inc. 0362-9011 0362-9011-10 10 CARTRIDGE in 1 CARTON (0362-9011-10) > 1.7 mL in 1 CARTRIDGE
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 077250 ANDA Septodont, Inc. 0362-9011 0362-9011-50 50 CARTRIDGE in 1 CARTON (0362-9011-50) > 1.8 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%;0.0091MG/ML
Approval Date:Sep 27, 2006TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

AstraZeneca
Daiichi Sankyo
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Citi
QuintilesIMS
Chinese Patent Office
Colorcon
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Moodys
US Army

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