ZYDUS PHARMS FDA Approval ANDA 211383

ANDA 211383

ZYDUS PHARMS

FDA Drug Application

Application #211383

Application Sponsors

ANDA 211383ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002
None (Tentative Approval)003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2019-11-20STANDARD
UNKNOWN; ORIG2TA2019-11-20STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211383
            [companyName] => ZYDUS PHARMS
            [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":"11\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/18\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-18
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.