NDA 212860

ROCKWELL MEDICAL INC

FDA Drug Application

Application #212860

Documents

• Letter: 2020-03-30
• Label: 2020-03-31
• Review: 2020-08-04

Application Sponsors

NDA 212860

ROCKWELL MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

6.75MG IRON/4.5ML (1.5MG IRON/ML)

1

TRIFERIC AVNU

FERRIC PYROPHOSPHATE CITRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2020-03-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ROCKWELL MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212860
            [companyName] => ROCKWELL MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIFERIC AVNU","activeIngredients":"FERRIC PYROPHOSPHATE CITRATE","strength":"6.75MG IRON\/4.5ML (1.5MG IRON\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/27\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212860s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/27\/2020","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\\\/2020\\\/212860s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212860Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-03-27
        )

)