Ketalar

NDA 16812, held by Ph Health. Ketamine Hydrochloride.

As of Nov 13, 2026, NDA 16812 (Ketalar), held by Ph Health, was first approved by FDA on Feb 19, 1970, with 26 approved supplements and 0 published complete response letters.

First approved: Feb 19, 1970
Review: Priority
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

KETALAR (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 27 submissions below


Jun 11, 1982	Supplement 23Efficacy (new indication or use)	Approved	None posted
Feb 19, 1970	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


KetalarEQ 10MG BASE/ML · injectable;injection	Ketamine Hydrochloride	RxReference drug
KetalarEQ 50MG BASE/ML · injectable;injection	Ketamine Hydrochloride	RxReference drug
KetalarEQ 100MG BASE/ML · injectable;injection	Ketamine Hydrochloride	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Mar 23, 2026	Supplement 57Labeling · Standard review	Approved	Label Letter
Mar 20, 2026	Supplement 59Labeling · Standard review	Approved	None posted
Oct 29, 2025	Supplement 56Labeling · Standard review	Approved	Letter Label
Aug 23, 2022	Supplement 52Manufacturing	Approved	Letter
Jun 3, 2022	Supplement 51Labeling · Standard review	Approved	Label Letter
Aug 24, 2020	Supplement 46Labeling · Standard review	Approved	Label Letter
Aug 7, 2018	Supplement 40Labeling · Standard review	Approved	Label
Apr 27, 2017	Supplement 43Labeling · Standard review	Approved	Letter Label
Mar 7, 2012	Supplement 39Labeling	Approved	Letter Label
Nov 14, 2002	Supplement 32Labeling · Standard review	Approved	Letter
Feb 14, 2001	Supplement 26Labeling · Standard review	Approved	None posted
Mar 29, 2000	Supplement 30Manufacturing · Priority review	Approved	None posted
Mar 14, 2000	Supplement 29Labeling · Standard review	Approved	None posted
Nov 17, 1998	Supplement 28Manufacturing · Priority review	Approved	None posted
Sep 5, 1997	Supplement 27Manufacturing · Priority review	Approved	None posted
Nov 29, 1994	Supplement 25Manufacturing · Priority review	Approved	None posted
Feb 7, 1989	Supplement 24Manufacturing · Priority review	Approved	None posted
Jun 11, 1982	Supplement 23Efficacy (new indication or use)	Approved	None posted
Aug 18, 1980	Supplement 22Labeling	Approved	None posted
Apr 4, 1980	Supplement 21Manufacturing · Priority review	Approved	None posted
Apr 4, 1980	Supplement 20Labeling	Approved	None posted
Jul 5, 1977	Supplement 19Labeling	Approved	None posted
May 16, 1977	Supplement 18Labeling	Approved	None posted
May 16, 1977	Supplement 17Manufacturing · Priority review	Approved	None posted
Jan 28, 1977	Supplement 15Labeling	Approved	None posted
May 14, 1976	Supplement 14Labeling	Approved	None posted
Feb 19, 1970	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 16812
Drugs@FDA: Overview at FDA
Company: PH Health

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