Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020118
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUPRANE DESFLURANE 99.9% LIQUID;INHALATION Prescription None 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
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
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

Label is not available on this site.

12/02/1999 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

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
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

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