SHANDONG FDA Approval ANDA 216373

ANDA 216373

SHANDONG

FDA Drug Application

Application #216373

Application Sponsors

ANDA 216373SHANDONG

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/ML0MILRINONE LACTATEMILRINONE LACTATE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

SHANDONG
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216373
            [companyName] => SHANDONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"MILRINONE LACTATE","activeIngredients":"MILRINONE LACTATE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/23\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-23
        )

)

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