Suprane

For agents other than SUPRANE and intubation. NDA 20118, held by Baxter Hlthcare. Desflurane.

As of Nov 13, 2026, NDA 20118 (Suprane), held by Baxter Hlthcare, was first approved by FDA on Sep 18, 1992, with 19 approved supplements and 0 published complete response letters.

First approved: Sep 18, 1992
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SUPRANE, a general anesthetic, is an inhalation agent indicated:

for induction and/or maintenance of anesthesia in adults
for maintenance of anesthesia in pediatric patients following induction with agents other than SUPRANE and intubation. 1.1 Induction of Anesthesia SUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults. SUPRANE is contraindicated as an inhalation agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Dec 15, 2006	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Sep 18, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Suprane100% · liquid;inhalation	Desflurane	RxReference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 1, 2022	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 1, 2019	Supplement 23Labeling · Standard review	Approved	Label
Mar 1, 2019	Supplement 22Manufacturing · Standard review	Approved	Label
Apr 27, 2017	Supplement 24Labeling · Standard review	Approved	Letter Label
Nov 4, 2016	Supplement 21Labeling · Standard review	Approved	Letter Label
Feb 26, 2015	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 27, 2013	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 23, 2013	Supplement 18Labeling · Standard review	Approved	Letter Label
Apr 5, 2010	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 14, 2009	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 15, 2006	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Aug 14, 2006	Supplement 11Labeling · Standard review	Approved	Letter Label
May 8, 2006	Supplement 10Labeling · Standard review	Approved	Label Letter
Aug 8, 2002	Supplement 8Manufacturing · Standard review	Approved	Review
Dec 2, 1999	Supplement 7Manufacturing · Standard review	Approved	Review
Dec 9, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 16, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 5, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Mar 26, 1993	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 18, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20118
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