ZYDUS PHARMS FDA Approval ANDA 207760

ANDA 207760

ZYDUS PHARMS

FDA Drug Application

Application #207760

Application Sponsors

ANDA 207760ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL62.5MG0BOSENTANBOSENTAN
002TABLET;ORAL125MG0BOSENTANBOSENTAN

FDA Submissions

UNKNOWN; ORIG1AP2019-04-26STANDARD
REMS; REMSSUPPL6AP2022-04-29

Submissions Property Types

ORIG1Null15
SUPPL6Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207760
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BOSENTAN","activeIngredients":"BOSENTAN","strength":"62.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BOSENTAN","activeIngredients":"BOSENTAN","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/01\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-01
        )

)

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