Ethrane

NDA 17087, held by Baxter Hlthcare. Enflurane.

As of Nov 14, 2026, NDA 17087 (Ethrane), held by Baxter Hlthcare, was first approved by FDA on Aug 28, 1972, with 40 approved supplements and 0 published complete response letters.

First approved: Aug 28, 1972
Review: Standard
Supplements approved: 40
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 41 submissions below

Date	Submission	Status	Documents
Aug 28, 1972	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ethrane99.9% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · liquid;inhalation	Enflurane	Discontinued

All 41 submissions, including labeling and manufacturing supplements


Jan 21, 2010	Supplement 48Labeling · Standard review	Approved	Letter Label
Sep 20, 2006	Supplement 47Labeling · Standard review	Approved	Letter Label
Oct 8, 2002	Supplement 45Labeling · Standard review	Approved	Letter
Sep 22, 2000	Supplement 44Manufacturing · Standard review	Approved	None posted
Dec 9, 1998	Supplement 43Manufacturing · Standard review	Approved	None posted
Jul 1, 1996	Supplement 42Manufacturing · Standard review	Approved	None posted
Jul 5, 1995	Supplement 41Labeling · Standard review	Approved	None posted
Mar 21, 1990	Supplement 40Manufacturing · Standard review	Approved	None posted
Feb 25, 1987	Supplement 39Manufacturing · Standard review	Approved	None posted
Apr 16, 1986	Supplement 38Manufacturing · Standard review	Approved	None posted
Apr 16, 1986	Supplement 37Labeling	Approved	None posted
Apr 16, 1986	Supplement 36Labeling	Approved	None posted
Apr 17, 1985	Supplement 33Labeling	Approved	None posted
Apr 17, 1985	Supplement 31Labeling	Approved	None posted
Mar 24, 1985	Supplement 35Labeling	Approved	None posted
Jun 6, 1984	Supplement 32Labeling	Approved	None posted
May 16, 1984	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 22, 1982	Supplement 28Labeling	Approved	None posted
Oct 28, 1981	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 24, 1981	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 24, 1980	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 10, 1980	Supplement 25Labeling	Approved	None posted
Dec 4, 1979	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 4, 1979	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 6, 1979	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 16, 1979	Supplement 22Manufacturing · Standard review	Approved	None posted
May 30, 1978	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 6, 1977	Supplement 19Labeling	Approved	None posted
Sep 10, 1977	Supplement 20Manufacturing · Standard review	Approved	None posted
May 3, 1977	Supplement 17Labeling	Approved	None posted
Nov 4, 1976	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 4, 1976	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 3, 1976	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 26, 1976	Supplement 11Labeling	Approved	None posted
Oct 7, 1975	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 4, 1975	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 16, 1975	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 18, 1975	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 11, 1974	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 17, 1974	Supplement 4	Approved	None posted
Aug 28, 1972	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17087
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