QUAGEN FDA Approval ANDA 212491

ANDA 212491

QUAGEN

FDA Drug Application

Application #212491

Application Sponsors

ANDA 212491QUAGEN

Marketing Status

Prescription001

Application Products

001TABLET;ORAL4MG0CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-24STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

QUAGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212491
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYPROHEPTADINE HYDROCHLORIDE","activeIngredients":"CYPROHEPTADINE HYDROCHLORIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/24\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-24
        )

)

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