TWI PHARMS FDA Approval ANDA 211832

ANDA 211832

TWI PHARMS

FDA Drug Application

Application #211832

Application Sponsors

ANDA 211832TWI PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL2.5MG0TERBUTALINE SULFATETERBUTALINE SULFATE
002TABLET;ORAL5MG0TERBUTALINE SULFATETERBUTALINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-22UNKNOWN

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TWI PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211832
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERBUTALINE SULFATE","activeIngredients":"TERBUTALINE SULFATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TERBUTALINE SULFATE","activeIngredients":"TERBUTALINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-19
        )

)

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