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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 076092


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NDA 076092 describes KETAMINE HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, and Hospira, and is included in five NDAs. It is available from nine 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. Twelve suppliers are listed for this compound. Additional details are available on the ketamine hydrochloride profile page.
Summary for 076092
Tradename:KETAMINE HYDROCHLORIDE
Applicant:Eugia Pharma
Ingredient:ketamine hydrochloride
Patents:0
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 Eugia US LLC 55150-438 55150-438-10 10 VIAL, MULTI-DOSE in 1 CARTON (55150-438-10) / 20 mL in 1 VIAL, MULTI-DOSE
KETAMINE HYDROCHLORIDE ketamine hydrochloride INJECTABLE;INJECTION 076092 ANDA Eugia US LLC 55150-439 55150-439-10 10 VIAL, MULTI-DOSE in 1 CARTON (55150-439-10) / 10 mL in 1 VIAL, MULTI-DOSE

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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