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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020118
Company: BAXTER HLTHCARE

Products on NDA 020118

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUPRANE	DESFLURANE	100%	LIQUID;INHALATION	Prescription	AN	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020118

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.

Labels for NDA 020118

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

Therapeutic Equivalents for NDA 020118

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

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