Forane

NDA 17624, held by Baxter Hlthcare. Isoflurane.

As of Nov 13, 2026, NDA 17624 (Forane), held by Baxter Hlthcare, was first approved by FDA on Dec 18, 1979, with 35 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1979
Review: Priority
Supplements approved: 35
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FORANE (isoflurane, USP) may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. FORANE, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below


Feb 22, 1982	Supplement 7Efficacy (new indication or use)	Approved	None posted
Dec 18, 1979	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Forane99.9% · liquid;inhalation	Isoflurane	RxReference drug

All 36 submissions, including labeling and manufacturing supplements


Dec 9, 2024	Supplement 43Labeling · Standard review	Approved	Label Letter
Nov 1, 2022	Supplement 42Labeling · Standard review	Approved	Letter Label
Oct 25, 2021	Supplement 40Labeling · Standard review	Approved	Letter Label
Apr 27, 2017	Supplement 41Labeling · Standard review	Approved	Letter Label
Feb 21, 2013	Supplement 39Manufacturing · Priority review	Approved	None posted
Feb 22, 2010	Supplement 36Labeling	Approved	Label Letter
Aug 31, 2006	Supplement 34Labeling · Standard review	Approved	Letter Label
Sep 27, 2002	Supplement 32Manufacturing · Priority review	Approved	None posted
Dec 1, 2000	Supplement 31Manufacturing · Priority review	Approved	None posted
Jul 23, 1999	Supplement 30Manufacturing · Priority review	Approved	None posted
May 14, 1999	Supplement 29Labeling · Standard review	Approved	None posted
Dec 9, 1998	Supplement 28Manufacturing · Priority review	Approved	None posted
Feb 26, 1997	Supplement 27Manufacturing · Priority review	Approved	None posted
Jul 1, 1996	Supplement 25Manufacturing · Priority review	Approved	None posted
Feb 9, 1996	Supplement 24Manufacturing · Priority review	Approved	None posted
Jul 5, 1995	Supplement 23Labeling · Standard review	Approved	None posted
Jan 16, 1990	Supplement 19Labeling	Approved	None posted
Feb 25, 1987	Supplement 18Manufacturing · Priority review	Approved	None posted
Apr 16, 1986	Supplement 17Manufacturing · Priority review	Approved	None posted
Apr 16, 1986	Supplement 16Labeling	Approved	None posted
Apr 16, 1986	Supplement 15Labeling	Approved	None posted
Oct 17, 1985	Supplement 14Labeling	Approved	None posted
Aug 2, 1985	Supplement 12Manufacturing · Priority review	Approved	None posted
Mar 15, 1985	Supplement 13Labeling	Approved	None posted
Nov 20, 1984	Supplement 11Manufacturing · Priority review	Approved	None posted
Jun 12, 1984	Supplement 8Labeling	Approved	None posted
Apr 1, 1983	Supplement 10Labeling	Approved	None posted
Feb 9, 1983	Supplement 9Manufacturing · Priority review	Approved	None posted
Jul 1, 1982	Supplement 2Labeling	Approved	None posted
Feb 22, 1982	Supplement 7Efficacy (new indication or use)	Approved	None posted
Sep 29, 1981	Supplement 6Manufacturing · Priority review	Approved	None posted
Jun 5, 1981	Supplement 5Manufacturing · Priority review	Approved	None posted
May 26, 1981	Supplement 4Labeling	Approved	None posted
May 26, 1981	Supplement 3Manufacturing · Priority review	Approved	None posted
May 26, 1981	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 18, 1979	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 17624
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