APOPHARMA INC FDA Approval NDA 212269

NDA 212269

APOPHARMA INC

FDA Drug Application

Application #212269

Documents

Label2020-05-20
Medication Guide2020-05-20
Letter2020-05-20

Application Sponsors

NDA 212269APOPHARMA INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL1000MG2FERRIPROXDEFERIPRONE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-05-19STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

CHIESI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212269
            [companyName] => CHIESI
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/212266s000lbl.pdf#page=14"]
            [products] => [{"drugName":"FERRIPROX","activeIngredients":"DEFERIPRONE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/19\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212266s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212266s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212269Orig1s000replacementltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)

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