HIKMA FDA Approval ANDA 214309

ANDA 214309

HIKMA

FDA Drug Application

Application #214309

Application Sponsors

ANDA 214309HIKMA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION150MG/ML0MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-05STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214309
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEDROXYPROGESTERONE ACETATE","activeIngredients":"MEDROXYPROGESTERONE ACETATE","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/05\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-05
        )

)

© 2023 FDA.report
This site is not affiliated with or endorsed by the FDA.