Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020118
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUPRANE | DESFLURANE | 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 |
---|---|---|---|---|---|---|---|
09/18/1992 | 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 |
---|---|---|---|---|---|
11/01/2022 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020118s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020118Orig1s026ltr.pdf | |
04/27/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020118s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020118Orig1s024ltr.pdf | |
03/01/2019 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020118s022,s023lbl.pdf | |
03/01/2019 | SUPPL-22 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020118s022,s023lbl.pdf | ||
11/04/2016 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020118s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020118Orig1s021ltr.pdf | |
02/26/2015 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020118s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020118Orig1s020ltr.pdf | |
09/27/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/23/2013 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020118s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020118Orig1s018ltr.pdf | |
04/05/2010 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020118s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020118s017ltr.pdf | |
04/14/2009 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020118s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020118s016ltr.pdf | |
12/15/2006 | SUPPL-12 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020118s012ltr.pdf | |
08/14/2006 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020118s011LTR.pdf | |
05/08/2006 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020118s010ltr.pdf | |
08/08/2002 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20118Orig1s008.pdf |
12/02/1999 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20118Orig1s007.pdf |
12/09/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/16/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/05/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/26/1993 | SUPPL-1 | Manufacturing (CMC) |
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-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020118s026lbl.pdf | |
03/01/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020118s022,s023lbl.pdf | |
03/01/2019 | SUPPL-22 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020118s022,s023lbl.pdf | |
04/27/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020118s024lbl.pdf | |
11/04/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020118s021lbl.pdf | |
02/26/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020118s020lbl.pdf | |
09/23/2013 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020118s018lbl.pdf | |
04/05/2010 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020118s017lbl.pdf | |
04/14/2009 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020118s016lbl.pdf | |
12/15/2006 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s012lbl.pdf | |
08/14/2006 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s011lbl.pdf | |
05/08/2006 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s010lbl.pdf |
SUPRANE
LIQUID;INHALATION; 100%
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESFLURANE | DESFLURANE | 100% | LIQUID;INHALATION | Prescription | No | AN | 208234 | SHANGHAI HENGRUI |
SUPRANE | DESFLURANE | 100% | LIQUID;INHALATION | Prescription | Yes | AN | 020118 | BAXTER HLTHCARE |