UBI FDA Approval ANDA 210223

ANDA 210223

UBI

FDA Drug Application

Application #210223

Application Sponsors

ANDA 210223UBI

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.004MG/ML0DESMOPRESSIN ACETATEDESMOPRESSIN ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

UBI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210223
            [companyName] => UBI
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESMOPRESSIN ACETATE","activeIngredients":"DESMOPRESSIN ACETATE","strength":"0.004MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-17
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.