Ketamine Hydrochloride

ANDA 74524, held by Hikma. Ketamine Hydrochloride.

As of Nov 15, 2026, ANDA 74524 (Ketamine Hydrochloride), held by Hikma, was first approved by FDA on Mar 22, 1996, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 22, 1996
Supplements approved: 7
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; all 8 submissions below

Date	Submission	Status	Documents
Mar 22, 1996	Original application	Approved	None posted

Products

2 strengths and forms


Ketamine HydrochlorideEQ 50MG BASE/ML · injectable;injection	Ketamine Hydrochloride	Rx
Ketamine HydrochlorideEQ 100MG BASE/ML · injectable;injection	Ketamine Hydrochloride	Rx

All 8 submissions, including labeling and manufacturing supplements


Apr 12, 2023	Supplement 19Labeling · Standard review	Approved	None posted
Apr 7, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Jun 3, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Jun 3, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Oct 11, 2012	Supplement 10Labeling · Standard review	Approved	None posted
Apr 3, 2001	Supplement 3Manufacturing	Approved	None posted
Sep 24, 1999	Supplement 1Labeling	Approved	None posted
Mar 22, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74524
Drugs@FDA: Overview at FDA
Company: Hikma

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