ANDA 210445

APOTEX INC

FDA Drug Application

Application #210445

Application Sponsors

ANDA 210445

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-08-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210445
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAVOPROST","activeIngredients":"TRAVOPROST","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-16
        )

)