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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076092

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NDA 076092 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 076092
Applicant:Mylan Institutional
Ingredient:ketamine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 076092
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 076092
Suppliers and Packaging for NDA: 076092
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETAMINE HYDROCHLORIDE ketamine hydrochloride INJECTABLE;INJECTION 076092 ANDA General Injectables and Vaccines, Inc. 52584-108 N 52584-108-00
KETAMINE HYDROCHLORIDE ketamine hydrochloride INJECTABLE;INJECTION 076092 ANDA Mylan Institutional LLC 67457-001 N 67457-001-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Sep 30, 2008TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Dec 28, 2001TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Oct 25, 2002TE:APRLD:No

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