ANDA 211406

APOTEX

FDA Drug Application

Application #211406

Application Sponsors

ANDA 211406

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

SIROLIMUS

SIROLIMUS

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-10-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211406
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-22
        )

)