ANDA 209554

MYLAN

FDA Drug Application

Application #209554

Application Sponsors

ANDA 209554

MYLAN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

300MG/5ML

0

TOBRAMYCIN

TOBRAMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209554
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"300MG\/5ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-13
        )

)