ANDA 211650

APOTEX INC

FDA Drug Application

Application #211650

Documents

• Letter: 2019-04-24

Application Sponsors

ANDA 211650

APOTEX INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET;ORAL	1MG	0	AXITINIB	AXITINIB
002	TABLET;ORAL	5MG	0	AXITINIB	AXITINIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-03-15

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211650
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AXITINIB","activeIngredients":"AXITINIB","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"AXITINIB","activeIngredients":"AXITINIB","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/15\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211650Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-15
        )

)