ANDA 216076

TEVA PHARMS

FDA Drug Application

Application #216076

Documents

• Letter: 2022-08-04

Application Sponsors

ANDA 216076

TEVA PHARMS

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-02-23

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216076
            [companyName] => TEVA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDOSTAURIN","activeIngredients":"MIDOSTAURIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-23
        )

)