AUROBINDO PHARMA LTD FDA Approval ANDA 206532

ANDA 206532

AUROBINDO PHARMA LTD

FDA Drug Application

Application #206532

Application Sponsors

ANDA 206532AUROBINDO PHARMA LTD

Marketing Status

Prescription001

Application Products

001SOLUTION;INHALATIONEQ 0.083% BASE;0.017%0ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEALBUTEROL SULFATE; IPRATROPIUM BROMIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-09STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAN

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206532
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE","activeIngredients":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","strength":"EQ 0.083% BASE;0.017%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-09
        )

)

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