HIKMA FARMACEUTICA FDA Approval ANDA 077966

ANDA 077966

HIKMA FARMACEUTICA

FDA Drug Application

Application #077966

Application Sponsors

ANDA 077966HIKMA FARMACEUTICA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/ML0MILRINONE LACTATEMILRINONE LACTATE

FDA Submissions

ORIG1AP2010-12-03

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

HIKMA FARMACEUTICA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77966
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MILRINONE LACTATE","activeIngredients":"MILRINONE LACTATE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MILRINONE LACTATE","submission":"MILRINONE LACTATE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.