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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Teva
Harvard Business School
Julphar
Boehringer Ingelheim
AstraZeneca
Cantor Fitzgerald
QuintilesIMS
Covington

Generated: October 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016964

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NDA 016964 describes MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, which is a drug marketed by Hospira and is included in one NDA. It is available from eight suppliers. Additional details are available on the MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE profile page.

The generic ingredient in MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE 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 NDA: 016964

Tradename:
4
Applicant:
1
Ingredient:
2
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 016964

Suppliers and Packaging for NDA: 016964

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MARCAINE HYDROCHLORIDE
bupivacaine hydrochloride
INJECTABLE;INJECTION 016964 NDA Hospira, Inc. 0409-1559 0409-1559-10 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-1559-10) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-1559-18)
MARCAINE HYDROCHLORIDE
bupivacaine hydrochloride
INJECTABLE;INJECTION 016964 NDA Hospira, Inc. 0409-1559 0409-1559-30 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1559-30) > 30 mL in 1 VIAL, SINGLE-DOSE (0409-1559-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%;0.0091MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Summary for product number 005

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cipla
AstraZeneca
Covington
Medtronic
Fuji
Julphar
US Department of Justice
QuintilesIMS
McKinsey

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