Documents
Application Sponsors
| NDA 206317 | ROCKWELL MEDICAL INC | |
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 27.2MG IRON/5ML (5.44MG IRON/ML) | 1 | TRIFERIC | FERRIC PYROPHOSPHATE CITRATE |
| 002 | SOLUTION;INTRAVENOUS | 272MG IRON/50ML (5.44MG IRON/ML) | 1 | TRIFERIC | FERRIC PYROPHOSPHATE CITRATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2015-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2015-09-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2016-05-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2015-11-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2016-07-28 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2017-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2018-03-29 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-07-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 33 |
| SUPPL | 12 | Null | 15 |
CDER Filings
ROCKWELL MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206317
[companyName] => ROCKWELL MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"TRIFERIC","activeIngredients":"FERRIC PYROPHOSPHATE CITRATE","strength":"27.2MG IRON\/5ML (5.44MG IRON\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"TRIFERIC","activeIngredients":"FERRIC PYROPHOSPHATE CITRATE","strength":"272MG IRON\/50ML (5.44MG IRON\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/29\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206317s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206317s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206317s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"01\/23\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206317s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206317Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206317Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206317Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"07\/10\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206317Orig1s012ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/29\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206317s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206317Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"10\/16\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206317s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206317Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"07\/28\/2016","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/12\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/16\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/10\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-07-10
)
)