Details for New Drug Application (NDA): 016812

NDA 016812 describes KETALAR, which is a drug marketed by Endo Operations and is included in one NDA. It is available from three suppliers. Additional details are available on the KETALAR profile page.

The generic ingredient in KETALAR 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 016812

Tradename:	KETALAR
Applicant:	Endo Operations
Ingredient:	ketamine hydrochloride
Patents:	0

Pharmacology for NDA: 016812

Physiological Effect

General Anesthesia

Medical Subject Heading (MeSH) Categories for 016812

Analgesics

Anesthetics, Dissociative

Excitatory Amino Acid Antagonists

Suppliers and Packaging for NDA: 016812

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETALAR	ketamine hydrochloride	INJECTABLE;INJECTION	016812	NDA	Henry Schein, Inc	0404-9880	0404-9880-20	1 VIAL in 1 BAG (0404-9880-20) / 20 mL in 1 VIAL
KETALAR	ketamine hydrochloride	INJECTABLE;INJECTION	016812	NDA	Endo USA, Inc.	42023-113	42023-113-10	10 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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