NDA 207949

ACCORD HLTHCARE INC

FDA Drug Application

Application #207949

Documents

• Letter: 2015-06-26
• Review: 2022-06-09

Application Sponsors

NDA 207949

ACCORD HLTHCARE INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML(60MG/3ML)

0

CABAZITAXEL

CABAZITAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2015-06-25

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

ACCORD HLTHCARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207949
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABAZITAXEL","activeIngredients":"CABAZITAXEL","strength":"20MG\/ML(60MG\/3ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/25\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207949Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-06-25
        )

)