Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | POWDER;ORAL | EQ 8.4GM BASE/PACKET | 1 | VELTASSA | PATIROMER SORBITEX CALCIUM |
| 002 | POWDER;ORAL | EQ 16.8GM BASE/PACKET | 1 | VELTASSA | PATIROMER SORBITEX CALCIUM |
| 003 | POWDER;ORAL | EQ 25.2GM BASE/PACKET | 1 | VELTASSA | PATIROMER SORBITEX CALCIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-10-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2016-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2016-06-16 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-11-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2016-12-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2018-05-02 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2021-05-14 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2021-12-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 35 | Null | 6 |
CDER Filings
RELYPSA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205739
[companyName] => RELYPSA INC
[docInserts] => ["",""]
[products] => [{"drugName":"VELTASSA","activeIngredients":"PATIROMER SORBITEX CALCIUM","strength":"EQ 8.4GM BASE\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VELTASSA","activeIngredients":"PATIROMER SORBITEX CALCIUM","strength":"EQ 16.8GM BASE\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VELTASSA","activeIngredients":"PATIROMER SORBITEX CALCIUM","strength":"EQ 25.2GM BASE\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/02\/2018","submission":"SUPPL-16","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205739s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205739s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205739s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205739s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205739s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205739s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205739s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205739Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205739Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/02\/2018","submission":"SUPPL-16","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205739s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205739Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"12\/01\/2016","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/25\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205739s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205739Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"06\/16\/2016","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/20\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205739s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205739Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2018-05-02
)
)