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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Mallinckrodt
Chinese Patent Office
Accenture
Harvard Business School
Deloitte
McKesson
Novartis
AstraZeneca

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207183

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NDA 207183 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Hospira, Mylan Asi, Baxter Hlthcare Corp, Septodont, and Intl Medicated, and is included in twenty-six NDAs. It is available from five suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are eleven 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 207183
Tradename:BUPIVACAINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:bupivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207183
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 207183
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 207183 ANDA AuroMedics Pharma LLC 55150-249 N 55150-249-50
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 207183 ANDA AuroMedics Pharma LLC 55150-250 N 55150-250-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:May 13, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:May 13, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Cerilliant
Colorcon
Mallinckrodt
McKesson
QuintilesIMS
US Army
Baxter
Dow

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