ANDA 210871

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210871

Application Sponsors

ANDA 210871

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

300MG/5ML

0

TOBRAMYCIN

TOBRAMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AN

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210871
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"300MG\/5ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-22
        )

)