EUGIA PHARMA FDA Approval ANDA 211285

ANDA 211285

EUGIA PHARMA

FDA Drug Application

Application #211285

Application Sponsors

ANDA 211285EUGIA PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL100MG0PROGESTERONEPROGESTERONE
002CAPSULE;ORAL200MG0PROGESTERONEPROGESTERONE

FDA Submissions

UNKNOWN; ORIG1AP2018-10-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

EUGIA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211285
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-26
        )

)

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