ANDA 210915

TEVA PHARMS USA

FDA Drug Application

Application #210915

Documents

• Letter: 2019-07-05

Application Sponsors

ANDA 210915

TEVA PHARMS USA

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

300MG/4ML

0

TOBRAMYCIN

TOBRAMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AN

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210915
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"300MG\/4ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210915Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-26
        )

)