Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011287
Company: CONCORDIA
Company: CONCORDIA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KAYEXALATE | SODIUM POLYSTYRENE SULFONATE | 453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;ORAL, RECTAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/28/2017 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011287s026lbl.pdf | |
| 01/03/2011 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011287s023lbl.pdf | |
| 09/02/2009 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s022lbl.pdf | |
| 04/24/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s021lbl.pdf |