ANDA 211195

APOTEX INC

FDA Drug Application

Application #211195

Documents

• Letter: 2021-10-08

Application Sponsors

ANDA 211195

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

10MG

0

MACITENTAN

MACITENTAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-09-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211195
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MACITENTAN","activeIngredients":"MACITENTAN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/01\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-01
        )

)