Etomidate

ANDA 202360, held by Zydus Pharms. Etomidate.

As of Nov 15, 2026, ANDA 202360 (Etomidate), held by Zydus Pharms, was first approved by FDA on Jul 18, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 18, 2014
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jul 18, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Etomidate2MG/ML · injectable;injection	Etomidate	Rx

All 2 submissions, including labeling and manufacturing supplements


Mar 7, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Jul 18, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202360
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters