NDA 20478, held by Abbvie. Sevoflurane.
As of Nov 14, 2026, NDA 20478 (Ultane), held by Abbvie, was first approved by FDA on Jun 7, 1995, with 27 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.
| Mar 30, 2001 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jun 7, 1995 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ultane100% · liquid;inhalation | Sevoflurane | RxReference drug |
| Feb 3, 2025 | Supplement 35Labeling · Standard review | Approved | |
| Nov 1, 2022 | Supplement 34Labeling · Standard review | Approved | |
| May 19, 2022 | Supplement 32Labeling · Standard review | Approved | |
| Mar 1, 2022 | Supplement 28Labeling · Standard review | Approved | |
| Mar 1, 2022 | Supplement 27Labeling · Standard review | Approved | |
| Mar 1, 2022 | Supplement 24Labeling · Standard review | Approved | |
| Mar 1, 2022 | Supplement 23Labeling · Standard review | Approved | |
| Apr 27, 2017 | Supplement 30Labeling · Standard review | Approved | |
| Oct 26, 2015 | Supplement 29Manufacturing · Standard review | Approved | |
| Mar 11, 2014 | Supplement 26Labeling · Standard review | Approved | |
| Mar 11, 2014 | Supplement 25Labeling · Standard review | Approved | |
| Aug 16, 2012 | Supplement 20Labeling · Standard review | Approved | |
| Aug 16, 2012 | Supplement 19Labeling · Standard review | Approved | |
| Jan 21, 2010 | Supplement 18Labeling · Standard review | Approved | |
| Jun 27, 2006 | Supplement 16Labeling · Standard review | Approved | |
| Jun 21, 2005 | Supplement 13Labeling · Standard review | Approved | |
| Jun 27, 2003 | Supplement 12Labeling · Standard review | Approved | |
| Dec 11, 2002 | Supplement 7Labeling · Standard review | Approved | |
| May 24, 2002 | Supplement 11Manufacturing · Standard review | Approved | |
| Sep 28, 2001 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Aug 9, 2001 | Supplement 10Labeling · Standard review | Approved | None posted |
| Mar 30, 2001 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Mar 14, 2001 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 16, 2000 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1998 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 23, 1997 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 2, 1997 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1995 | Original applicationNew molecular entity · Standard review | Approved |
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
