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Serving leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018692

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NDA 018692 describes MARCAINE, which is a drug marketed by Hospira and is included in two NDAs. It is available from one supplier. Additional details are available on the MARCAINE profile page.

The generic ingredient in MARCAINE 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 018692
Ingredient:bupivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 018692
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 018692
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MARCAINE bupivacaine hydrochloride INJECTABLE;SPINAL 018692 NDA Hospira, Inc. 0409-1761 N 0409-1761-02
MARCAINE bupivacaine hydrochloride INJECTABLE;SPINAL 018692 NDA Hospira, Inc. 0409-1761 N 0409-1761-62

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SPINALStrength0.75%
Approval Date:May 4, 1984TE:APRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Queensland Health

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