ANDA 209878

MSN

FDA Drug Application

Application #209878

Documents

• Letter: 2019-12-10

Application Sponsors

ANDA 209878

MSN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, FOR SUSPENSION;ORAL	125MG	0	DEFERASIROX	DEFERASIROX
002	TABLET, FOR SUSPENSION;ORAL	250MG	0	DEFERASIROX	DEFERASIROX
003	TABLET, FOR SUSPENSION;ORAL	500MG	0	DEFERASIROX	DEFERASIROX

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-11-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MSN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209878
            [companyName] => MSN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"125MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"250MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"500MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209878Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-20
        )

)