ANDA 206126, held by Eugia Pharma. Etomidate.
As of Nov 15, 2026, ANDA 206126 (Etomidate), held by Eugia Pharma, was first approved by FDA on Feb 24, 2017, with 2 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE SECTION 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 24, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Etomidate2MG/ML · injectable;injection | Etomidate | Rx |
| Aug 2, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 8, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 24, 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
