INTL MEDICATION SYS FDA Approval ANDA 203449

ANDA 203449

INTL MEDICATION SYS

FDA Drug Application

Application #203449

Application Sponsors

ANDA 203449INTL MEDICATION SYS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1MEQ/ML0SODIUM BICARBONATESODIUM BICARBONATE

FDA Submissions

UNKNOWN; ORIG1AP2017-09-19

Submissions Property Types

ORIG1Null29

TE Codes

001PrescriptionAP

CDER Filings

INTL MEDICATION SYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203449
            [companyName] => INTL MEDICATION SYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"1MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-19
        )

)

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