ANDA 204230

APOTEX INC

FDA Drug Application

Application #204230

Documents

• Letter: 2017-09-07

Application Sponsors

ANDA 204230

APOTEX INC

Marketing Status

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

Application Products

002

POWDER; IV (INFUSION)

100MG/VIAL

0

BENDAMUSTINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-08-18

STANDARD

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204230
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"25MG\/VIAL","dosageForm":"POWDER; IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/VIAL","dosageForm":"POWDER; IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204230Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-18
        )

)