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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021321
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXTRANEAL ICODEXTRIN 7.5GM/100ML SOLUTION;INTRAPERITONEAL 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
12/20/2002 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21321_Extraneal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21321ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21321_Extraneal.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/2019 SUPPL-37 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021321s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021321Orig1s037ltr.pdf
10/24/2016 SUPPL-35 REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021321Orig1s035ltr.pdf
12/16/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021321s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021321Orig1s034ltr.pdf
08/01/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/16/2015 SUPPL-32 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021321s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021321Orig1s032ltr.pdf
02/04/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/25/2014 SUPPL-29 REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021321Orig1s029ltr.pdf
12/09/2014 SUPPL-28 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021321Orig1s028ltr.pdf
04/26/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/09/2011 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021321s020,s021ltr.pdf
03/09/2011 SUPPL-20 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021321s020,s021ltr.pdf
01/29/2009 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021321s018ltr.pdf
04/07/2009 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021321s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021321s017ltr.pdf
02/23/2007 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021321s013ltr.pdf
12/17/2004 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21321s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21321s010ltr.pdf
05/24/2005 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021321s009ltr.pdf
05/24/2005 SUPPL-8 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021321s008ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/04/2019 SUPPL-37 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021321s037lbl.pdf
12/16/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021321s034lbl.pdf
10/16/2015 SUPPL-32 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021321s032lbl.pdf
03/09/2011 SUPPL-21 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf
03/09/2011 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf
03/09/2011 SUPPL-21 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf
03/09/2011 SUPPL-20 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf
04/07/2009 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021321s017lbl.pdf
12/17/2004 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21321s010lbl.pdf
12/20/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21321_Extraneal_lbl.pdf
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