ANDA 207693

ACCORD HLTHCARE INC

FDA Drug Application

Application #207693

Application Sponsors

ANDA 207693

ACCORD HLTHCARE INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

60MG/1.5ML(40MG/ML)

0

CABAZITAXEL

CABAZITAXEL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-10-24

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207693
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABAZITAXEL","activeIngredients":"CABAZITAXEL","strength":"60MG\/1.5ML(40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/24\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-24
        )

)