ASPEN FDA Approval ANDA 211777

ANDA 211777

ASPEN

FDA Drug Application

Application #211777

Application Sponsors

ANDA 211777ASPEN

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAMUSCULAR250MG/ML (250MG/ML)0HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATE

FDA Submissions

UNKNOWN; ORIG1AP2019-08-08STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

ASPEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211777
            [companyName] => ASPEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYPROGESTERONE CAPROATE","activeIngredients":"HYDROXYPROGESTERONE CAPROATE","strength":"250MG\/ML (250MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-08
        )

)

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