Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205739
Company: RELYPSA INC
Company: RELYPSA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VELTASSA | PATIROMER SORBITEX CALCIUM | EQ 8.4GM BASE/PACKET | POWDER;ORAL | Prescription | None | Yes | No |
| VELTASSA | PATIROMER SORBITEX CALCIUM | EQ 16.8GM BASE/PACKET | POWDER;ORAL | Prescription | None | Yes | No |
| VELTASSA | PATIROMER SORBITEX CALCIUM | EQ 25.2GM BASE/PACKET | POWDER;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/21/2015 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205739s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205739Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205739Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/02/2018 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205739s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205739Orig1s016ltr.pdf | |
| 12/01/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/2016 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205739Orig1s009ltr.pdf | |
| 06/16/2016 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2016 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2016 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205739Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/02/2018 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205739s016lbl.pdf | |
| 11/25/2016 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf | |
| 11/25/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf | |
| 05/20/2016 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf | |
| 05/20/2016 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf | |
| 10/21/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205739s000lbl.pdf |
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