Ketamine Hydrochloride

ANDA 219684, held by Baxter Hlthcare Corp. Ketamine Hydrochloride.

As of Nov 15, 2026, ANDA 219684 (Ketamine Hydrochloride), held by Baxter Hlthcare Corp, was first approved by FDA on Sep 17, 2025, with 0 approved supplements and 0 published complete response letters.

First approved: Sep 17, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Sep 17, 2025	Original application	Approved	None posted

Products

2 strengths and forms


Ketamine HydrochlorideEQ 100MG BASE/10ML (EQ 10MG BASE/ML) · solution;intramuscular, intravenous	Ketamine Hydrochloride	Discontinued
Ketamine HydrochlorideEQ 50MG BASE/5ML (EQ 10MG BASE/ML) · solution;intramuscular, intravenous	Ketamine Hydrochloride	Rx

Identifiers

Application: ANDA 219684
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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