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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Dow
Fish and Richardson
US Department of Justice
Medtronic
Chinese Patent Office
Harvard Business School
McKinsey
Covington

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074549

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NDA 074549 describes KETAMINE HYDROCHLORIDE, which is a drug marketed by Hospira, Mylan Institutional, and West-ward Pharms Int, and is included in three NDAs. It is available from six suppliers. Additional details are available on the KETAMINE HYDROCHLORIDE profile page.

The generic ingredient in KETAMINE HYDROCHLORIDE is ketamine hydrochloride. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ketamine hydrochloride profile page.
Summary for 074549
Tradename:KETAMINE HYDROCHLORIDE
Applicant:Hospira
Ingredient:ketamine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074549
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 074549
Suppliers and Packaging for NDA: 074549
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETAMINE HYDROCHLORIDE ketamine hydrochloride INJECTABLE;INJECTION 074549 ANDA Hospira, Inc. 0409-2051 N 0409-2051-05
KETAMINE HYDROCHLORIDE ketamine hydrochloride INJECTABLE;INJECTION 074549 ANDA Hospira, Inc. 0409-2053 N 0409-2053-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Jun 27, 1996TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Jun 27, 1996TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Teva
QuintilesIMS
Colorcon
US Army
Dow
Fuji
Cipla
Daiichi Sankyo

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