Last Updated: November 8, 2026

Details for New Drug Application (NDA): 209058

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NDA 209058 describes ETOMIDATE, which is a drug marketed by Avet Lifesciences, Caplin, Eugia Pharma, Gland, Hikma, Luitpold, Mylan Labs Ltd, Ph Health, Rising, and Zydus Pharms, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the ETOMIDATE profile page.

The generic ingredient in ETOMIDATE is etomidate. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the etomidate profile page.

Summary for 209058

Tradename:	ETOMIDATE
Applicant:	Gland
Ingredient:	etomidate
Patents:	0

Pharmacology for NDA: 209058

Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for 209058

Anesthetics, Intravenous
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 209058

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETOMIDATE	etomidate	INJECTABLE;INJECTION	209058	ANDA	Gland Pharma Limited	68083-234	68083-234-10	10 VIAL in 1 CARTON (68083-234-10) / 10 mL in 1 VIAL (68083-234-01)
ETOMIDATE	etomidate	INJECTABLE;INJECTION	209058	ANDA	Gland Pharma Limited	68083-235	68083-235-10	10 VIAL in 1 CARTON (68083-235-10) / 20 mL in 1 VIAL (68083-235-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Apr 18, 2017	TE:	AP	RLD:	No

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