Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020478
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTANE SEVOFLURANE 100% LIQUID;INHALATION Prescription AN Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/07/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2017 SUPPL-30 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020478s030lbl.pdf
10/26/2015 SUPPL-29 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020478Orig1S029.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020478Orig1S029.pdf
03/11/2014 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020478Orig1s025,s026ltr.pdf
03/11/2014 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020478Orig1s025,s026ltr.pdf
08/16/2012 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020478Orig1s019,s020ltr.pdf
08/16/2012 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020478Orig1s019,s020ltr.pdf
01/21/2010 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020478s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020478s018ltr.pdf
06/27/2006 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020478s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020478s016ltr.pdf
06/21/2005 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020478s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020478s013ltr.pdf
06/27/2003 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20478slr012ltr.pdf
05/24/2002 SUPPL-11 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020478Orig1S011.pdf
08/09/2001 SUPPL-10 Labeling

Label is not available on this site.

09/28/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/2002 SUPPL-7 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20478slr007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020478s007TOC.cfm
03/30/2001 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20478S6LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20478S6LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020478_S006_ULTANE_AP.pdf
06/16/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/06/1998 SUPPL-3 Labeling

Label is not available on this site.

12/23/1997 SUPPL-2 Labeling

Label is not available on this site.

07/02/1997 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/27/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020478s030lbl.pdf
10/26/2015 SUPPL-29 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020478Orig1S029.pdf
03/11/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf
03/11/2014 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf
08/16/2012 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf
08/16/2012 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf
01/21/2010 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020478s018lbl.pdf
06/27/2006 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020478s016lbl.pdf
06/21/2005 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020478s013lbl.pdf
03/30/2001 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20478S6LBL.PDF

ULTANE

LIQUID;INHALATION; 100%
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SEVOFLURANE SEVOFLURANE 100% LIQUID;INHALATION Prescription No AN 075895 BAXTER HLTHCARE
SEVOFLURANE SEVOFLURANE 100% LIQUID;INHALATION Prescription No AN 078650 HALOCARBON PRODS
SEVOFLURANE SEVOFLURANE 100% LIQUID;INHALATION Prescription No AN 203793 SHANGHAI HENGRUI
SOJOURN SEVOFLURANE 100% LIQUID;INHALATION Prescription No AN 077867 PIRAMAL CRITICAL
ULTANE SEVOFLURANE 100% LIQUID;INHALATION Prescription Yes AN 020478 ABBVIE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English