HIKMA FDA Approval ANDA 203723

ANDA 203723

HIKMA

FDA Drug Application

Application #203723

Application Sponsors

ANDA 203723HIKMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION10MG/ML0ESTRADIOL VALERATEESTRADIOL VALERATE
002INJECTABLE;INJECTION20MG/ML0ESTRADIOL VALERATEESTRADIOL VALERATE
003INJECTABLE;INJECTION40MG/ML0ESTRADIOL VALERATEESTRADIOL VALERATE

FDA Submissions

UNKNOWN; ORIG1AP2020-04-21

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAO
002PrescriptionAO
003PrescriptionAO

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203723
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL VALERATE","activeIngredients":"ESTRADIOL VALERATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL VALERATE","activeIngredients":"ESTRADIOL VALERATE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL VALERATE","activeIngredients":"ESTRADIOL VALERATE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-21
        )

)

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