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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Mallinckrodt
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Deloitte
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Daiichi Sankyo
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Generated: June 24, 2017

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Details for New Drug Application (NDA): 071165

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NDA 071165 describes BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, which is a drug marketed by Septodont and Hospira 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. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine profile page.

Summary for NDA: 071165

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

Pharmacology for NDA: 071165

Suppliers and Packaging for NDA: 071165

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
bupivacaine hydrochloride; epinephrine
INJECTABLE;INJECTION 071165 ANDA Hospira, Inc. 0409-9042 0409-9042-01 10 VIAL, SINGLE-USE in 1 CARTON (0409-9042-01) > 10 mL in 1 VIAL, SINGLE-USE (0409-9042-11)
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
bupivacaine hydrochloride; epinephrine
INJECTABLE;INJECTION 071165 ANDA Hospira, Inc. 0409-9042 0409-9042-17 25 VIAL, SINGLE-USE in 1 CARTON (0409-9042-17) > 30 mL in 1 VIAL, SINGLE-USE (0409-9042-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%;0.005MG/ML
Approval Date:Jun 16, 1988TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Medtronic
Boehringer Ingelheim
Federal Trade Commission
Colorcon
Harvard Business School
Merck
Novartis
Accenture
Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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