QUAGEN FDA Approval ANDA 214238

ANDA 214238

QUAGEN

FDA Drug Application

Application #214238

Application Sponsors

ANDA 214238QUAGEN

Marketing Status

Prescription001

Application Products

001SYRUP;ORAL10MG/5ML;6.25MG/5ML0PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

QUAGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214238
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE","activeIngredients":"CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE","strength":"10MG\/5ML;6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-08
        )

)

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