ANDA 211350

TEVA PHARMS USA INC

FDA Drug Application

Application #211350

Documents

• Letter: 2021-04-13

Application Sponsors

ANDA 211350

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

UNKNOWN

UNKNOWN

0

IBRUTINIB

IBRUTINIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-03-01

UNKNOWN

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211350
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/01\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-01
        )

)