ANDA 203628

MYLAN LABS LTD

FDA Drug Application

Application #203628

Application Sponsors

ANDA 203628

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

500MG

0

PEMETREXED

PEMETREXED

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-08-28

Submissions Property Types

ORIG

1

Null

19

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203628
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"500MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/28\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-28
        )

)