ASPIRO FDA Approval ANDA 213810

ANDA 213810

ASPIRO

FDA Drug Application

Application #213810

Application Sponsors

ANDA 213810ASPIRO

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION20MG/ML0SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-05-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

ASPIRO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213810
            [companyName] => ASPIRO
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/16\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-11-16
        )

)

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