AMRING PHARMS FDA Approval ANDA 211237

ANDA 211237

AMRING PHARMS

FDA Drug Application

Application #211237

Application Sponsors

ANDA 211237AMRING PHARMS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.2MG/ML0ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-05-19STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

AMRING PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211237
            [companyName] => AMRING PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOPROTERENOL HYDROCHLORIDE","activeIngredients":"ISOPROTERENOL HYDROCHLORIDE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-19
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.