ANDA 212220

MYLAN PHARMS INC

FDA Drug Application

Application #212220

Documents

• Letter: 2022-08-01

Application Sponsors

ANDA 212220

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

2.5MG

0

RIVAROXABAN

RIVAROXABAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-06-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212220
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIVAROXABAN","activeIngredients":"RIVAROXABAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-27
        )

)