ANDA 213823

BAXTER HLTHCARE CORP

FDA Drug Application

Application #213823

Application Sponsors

ANDA 213823

BAXTER HLTHCARE CORP

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

3.5MG/VIAL

0

BORTEZOMIB

BORTEZOMIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-07-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

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
        )

)