ANDA 213913

MYLAN PHARMS INC

FDA Drug Application

Application #213913

Application Sponsors

ANDA 213913

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

002

INJECTABLE;INJECTION

1.5MG

0

EPOPROSTENOL

EPOPROSTENOL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-04-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213913
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPOPROSTENOL","activeIngredients":"EPOPROSTENOL","strength":"0.5MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EPOPROSTENOL","activeIngredients":"EPOPROSTENOL","strength":"1.5MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/11\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-11
        )

)