ANDA 209633

BRECKENRIDGE PHARMS

FDA Drug Application

Application #209633

Documents

• Letter: 2021-07-07

Application Sponsors

ANDA 209633

BRECKENRIDGE PHARMS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

5MG

0

TOFACITINIB

TOFACITINIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-06-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

BRECKENRIDGE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209633
            [companyName] => BRECKENRIDGE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOFACITINIB","activeIngredients":"TOFACITINIB","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/10\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209633Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-10
        )

)