APOTEX INC FDA Approval ANDA 207736

ANDA 207736

APOTEX INC

FDA Drug Application

Application #207736

Documents

Letter2018-08-20

Application Sponsors

ANDA 207736APOTEX INC

Marketing Status

None (Tentative Approval)001

Application Products

001SOLUTION;IV (INFUSION)60MG/1.5ML (40MG/ML)0CABAZITAXELCABAZITAXEL

FDA Submissions

UNKNOWN; ORIG1TA2018-07-11STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207736
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABAZITAXEL","activeIngredients":"CABAZITAXEL","strength":"60MG\/1.5ML (40MG\/ML)","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/11\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207736Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-11
        )

)

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