EXELA PHARMA FDA Approval ANDA 212071

ANDA 212071

EXELA PHARMA

FDA Drug Application

Application #212071

Application Sponsors

ANDA 212071EXELA PHARMA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 0.4MG COPPER/ML0CUPRIC CHLORIDECUPRIC CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-31STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

EXELA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212071
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CUPRIC CHLORIDE","activeIngredients":"CUPRIC CHLORIDE","strength":"EQ 0.4MG COPPER\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-31
        )

)

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