CIPLA FDA Approval ANDA 211852

ANDA 211852

CIPLA

FDA Drug Application

Application #211852

Application Sponsors

ANDA 211852CIPLA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL90MG0DEFERASIROXDEFERASIROX
002TABLET;ORAL360MG0DEFERASIROXDEFERASIROX
003TABLET;ORAL180MG0DEFERASIROXDEFERASIROX

FDA Submissions

UNKNOWN; ORIG1AP2020-02-11STANDARD
UNKNOWN; ORIG2TA2020-02-11STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

CIPLA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211852
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"90MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"360MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/15\/2020","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-15
        )

)

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