ANDA 220602, held by Neurorx. Ketamine Hydrochloride.
As of Nov 15, 2026, ANDA 220602 (Ketamine Hydrochloride), held by Neurorx, was first approved by FDA on Oct 28, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ketamine HydrochlorideEQ 50MG BASE/5ML (EQ 10MG BASE/ML) ยท solution;intramuscular, intravenous | Ketamine Hydrochloride | Rx |
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
