Halothane

ANDA 80810, held by Halocarbon. Halothane.

As of Nov 15, 2026, ANDA 80810 (Halothane), held by Halocarbon, was first approved by FDA on May 9, 1972, with 9 approved supplements and 0 published complete response letters.

First approved: May 9, 1972
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
May 9, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Halothane99.99% · liquid;inhalation	Halothane	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Apr 10, 2001	Supplement 23Labeling	Approved	None posted
Mar 19, 2001	Supplement 22Manufacturing	Approved	None posted
Jul 29, 1998	Supplement 21Labeling	Approved	None posted
Apr 7, 1997	Supplement 20Manufacturing	Approved	None posted
Feb 17, 1993	Supplement 19Manufacturing	Approved	None posted
May 19, 1989	Supplement 17Manufacturing	Approved	None posted
Dec 23, 1988	Supplement 16Manufacturing	Approved	None posted
Apr 7, 1988	Supplement 18Manufacturing	Approved	None posted
Jun 21, 1982	Supplement 14Manufacturing	Approved	None posted
May 9, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80810
Drugs@FDA: Overview at FDA
Company: Halocarbon

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