NDA 208551

ROCKWELL MEDICAL INC

FDA Drug Application

Application #208551

Documents

• Letter: 2016-04-27
• Label: 2016-04-27
• Review: 2016-10-21
• Summary Review: 2016-10-21
• Label: 2017-10-17
• Letter: 2017-10-19
• Label: 2018-04-01
• Letter: 2018-04-01

Application Sponsors

NDA 208551

ROCKWELL MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;INTRAVENOUS

272MG IRON/PACKET

1

TRIFERIC

FERRIC PYROPHOSPHATE CITRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2016-04-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-10-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2018-03-29	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	6
SUPPL	5	Null	15

CDER Filings

ROCKWELL MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208551
            [companyName] => ROCKWELL MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIFERIC","activeIngredients":"FERRIC PYROPHOSPHATE CITRATE","strength":"272MG IRON\/PACKET","dosageForm":"FOR SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/29\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208551s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208551s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208551s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208551s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208551Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208551Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208341Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/29\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208551s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208551Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"10\/16\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208551s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208551Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-03-29
        )

)