ANDA 078320

INVAGEN PHARMS

FDA Drug Application

Application #078320

Documents

• Other Important Information from FDA: 2007-06-18

Application Sponsors

ANDA 078320

INVAGEN PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	1MG	0	TRANDOLAPRIL	TRANDOLAPRIL
002	TABLET;ORAL	2MG	0	TRANDOLAPRIL	TRANDOLAPRIL
003	TABLET;ORAL	4MG	0	TRANDOLAPRIL	TRANDOLAPRIL

FDA Submissions

ORIG

1

AP

2007-06-12

Submissions Property Types

SUPPL

1

Null

15

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78320
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANDOLAPRIL","activeIngredients":"TRANDOLAPRIL","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANDOLAPRIL","activeIngredients":"TRANDOLAPRIL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANDOLAPRIL","activeIngredients":"TRANDOLAPRIL","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRANDOLAPRIL","submission":"TRANDOLAPRIL","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANDOLAPRIL","submission":"TRANDOLAPRIL","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANDOLAPRIL","submission":"TRANDOLAPRIL","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)