Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021321
Company: BAXTER HLTHCARE
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 |
|---|---|---|---|---|---|
| 04/22/2024 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021321s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021321Orig1s038ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 04/22/2024 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021321s038lbl.pdf | |
| 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 |