BAXTER HLTHCARE CORP FDA Approval ANDA 213823

ANDA 213823

BAXTER HLTHCARE CORP

FDA Drug Application

Application #213823

Application Sponsors

ANDA 213823BAXTER HLTHCARE CORP

Marketing Status

None (Tentative Approval)001

Application Products

001INJECTABLE;INTRAVENOUS, SUBCUTANEOUS3.5MG/VIAL0BORTEZOMIBBORTEZOMIB

FDA Submissions

UNKNOWN; ORIG1TA2021-07-16STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213823
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"3.5MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/16\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-16
        )

)

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