EYWA FDA Approval ANDA 213524

ANDA 213524

EYWA

FDA Drug Application

Application #213524

Application Sponsors

ANDA 213524EYWA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 2MG BASE0ALBUTEROL SULFATEALBUTEROL SULFATE
002TABLET;ORALEQ 4MG BASE0ALBUTEROL SULFATEALBUTEROL SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-08STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

EYWA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213524
            [companyName] => EYWA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-08
        )

)

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