ANDA 216809, held by Gland. Ketamine Hydrochloride.
As of Nov 15, 2026, ANDA 216809 (Ketamine Hydrochloride), held by Gland, was first approved by FDA on Jan 24, 2023, with 1 approved supplement and 0 published complete response letters.
Ketamine hydrochloride injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. for the induction of anesthesia prior to the administration of other general anesthetic agents. as a supplement to other anesthetic agents.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 24, 2023 | Original application | Approved | None posted |
| Ketamine HydrochlorideEQ 10MG BASE/ML · injectable;injection | Ketamine Hydrochloride | Rx |
| Ketamine HydrochlorideEQ 50MG BASE/ML · injectable;injection | Ketamine Hydrochloride | Rx |
| Ketamine HydrochlorideEQ 100MG BASE/ML · injectable;injection | Ketamine Hydrochloride | Rx |
| Mar 27, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 24, 2023 | 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
