STRIDES PHARMA FDA Approval ANDA 209177

ANDA 209177

STRIDES PHARMA

FDA Drug Application

Application #209177

Application Sponsors

ANDA 209177STRIDES PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL12.5MG0PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
002TABLET;ORAL25MG0PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
003TABLET;ORAL50MG0PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-06-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209177
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-30
        )

)

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