Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020478
Company: ABBVIE
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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020478Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020478Orig1s034ltr.pdf | |
| 05/19/2022 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020478Orig1s032ltr.pdf | |
| 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 | |
| 03/01/2022 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s023s024s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020478Orig1s023,s024,s027,s028ltr.pdf | |
| 03/01/2022 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s023s024s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020478Orig1s023,s024,s027,s028ltr.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 | |
| 03/01/2022 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s023s024s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020478Orig1s023,s024,s027,s028ltr.pdf | |
| 03/01/2022 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s023s024s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020478Orig1s023,s024,s027,s028ltr.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 |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s034lbl.pdf | |
| 05/19/2022 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s032lbl.pdf | |
| 03/01/2022 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s023s024s027s028lbl.pdf | |
| 03/01/2022 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s023s024s027s028lbl.pdf | |
| 03/01/2022 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s023s024s027s028lbl.pdf | |
| 03/01/2022 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020478s023s024s027s028lbl.pdf | |
| 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 | 214382 | SHANDONG |
| 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 |