NDA 212269

APOPHARMA INC

FDA Drug Application

Application #212269

Documents

• Label: 2020-05-20
• Medication Guide: 2020-05-20
• Letter: 2020-05-20
• Review: 2020-11-30
• Label: 2021-05-03
• Medication Guide: 2021-05-03
• Letter: 2021-05-04
• Letter: 2021-12-01
• Label: 2021-12-01
• Medication Guide: 2021-12-01

Application Sponsors

NDA 212269

APOPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1000MG

2

FERRIPROX

DEFERIPRONE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2020-05-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-11-30	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	15

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
        )

)