Last Updated: September 24, 2026

Details for New Drug Application (NDA): 201044

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NDA 201044 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 201044

Tradename:	ETOMIDATE
Applicant:	Mylan Labs Ltd
Ingredient:	etomidate
Patents:	0

Pharmacology for NDA: 201044

Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for 201044

Anesthetics, Intravenous
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 201044

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETOMIDATE	etomidate	INJECTABLE;INJECTION	201044	ANDA	Mylan Institutional LLC	67457-902	67457-902-10	10 VIAL in 1 CARTON (67457-902-10) / 10 mL in 1 VIAL (67457-902-00)
ETOMIDATE	etomidate	INJECTABLE;INJECTION	201044	ANDA	Mylan Institutional LLC	67457-903	67457-903-20	10 VIAL in 1 CARTON (67457-903-20) / 20 mL in 1 VIAL (67457-903-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Feb 7, 2017	TE:	AP	RLD:	No

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