ANDA 205533

APOTEX INC

FDA Drug Application

Application #205533

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 205533

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

VIAL

3.5MG/VIAL

0

BORTEZOMIB

BORTEZOMIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-05-12

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205533
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"3.5MG\/VIAL","dosageForm":"VIAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/12\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-12
        )

)