NDA 210601

APOTEX INC

FDA Drug Application

Application #210601

Documents

• Letter: 2018-12-20

Application Sponsors

NDA 210601

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-11-13

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210601
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/4ML (25MG\/ML)","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/13\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210601Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-13
        )

)