STI PHARMA LLC FDA Approval ANDA 215542

ANDA 215542

STI PHARMA LLC

FDA Drug Application

Application #215542

Application Sponsors

ANDA 215542STI PHARMA LLC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.2MG/ML0ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

STI PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215542
            [companyName] => STI PHARMA LLC
            [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":"09\/20\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-20
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.