ANDA 201044, held by Mylan Labs Ltd. Etomidate.
As of Nov 15, 2026, ANDA 201044 (Etomidate), held by Mylan Labs Ltd, was first approved by FDA on Feb 7, 2017, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Etomidate injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate injection, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ). Intravenous etomidate injection is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Etomidate2MG/ML · injectable;injection | Etomidate | Rx |
| Mar 7, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 7, 2017 | Original application | Approved | None posted |
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
