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 |
| 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 |