ANDA 065477

ZYDUS PHARMS USA INC

FDA Drug Application

Application #065477

Documents

• Other Important Information from FDA: 2009-07-15

Application Sponsors

ANDA 065477

ZYDUS PHARMS USA INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL

FDA Submissions

ORIG

1

AP

2009-05-04

Submissions Property Types

ORIG

1

Null

0

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65477
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOPHENOLATE MOFETIL","submission":"MYCOPHENOLATE MOFETIL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)