ZYDUS PHARMS FDA Approval ANDA 208884

ANDA 208884

ZYDUS PHARMS

FDA Drug Application

Application #208884

Application Sponsors

ANDA 208884ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 2MG BASE0ALBUTEROL SULFATEALBUTEROL SULFATE
002TABLET;ORALEQ 4MG BASE0ALBUTEROL SULFATEALBUTEROL SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208884
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-22
        )

)

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