ANDA 207735

BPI LABS LLC

FDA Drug Application

Application #207735

Documents

• Letter: 2018-06-05

Application Sponsors

ANDA 207735

BPI LABS LLC

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-05-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

BPI LABS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207735
            [companyName] => BPI LABS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABAZITAXEL","activeIngredients":"CABAZITAXEL","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/22\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207735Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-22
        )

)