ANDA 078138

ANI PHARMS INC

FDA Drug Application

Application #078138

Documents

• Letter: 2009-11-13

Application Sponsors

ANDA 078138

ANI PHARMS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	2MG	0	PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE
002	TABLET;ORAL	4MG	0	PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE
003	TABLET;ORAL	8MG	0	PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE

FDA Submissions

ORIG

1

AP

2009-11-10

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78138
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERINDOPRIL ERBUMINE","activeIngredients":"PERINDOPRIL ERBUMINE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PERINDOPRIL ERBUMINE","activeIngredients":"PERINDOPRIL ERBUMINE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PERINDOPRIL ERBUMINE","activeIngredients":"PERINDOPRIL ERBUMINE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PERINDOPRIL ERBUMINE","submission":"PERINDOPRIL ERBUMINE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PERINDOPRIL ERBUMINE","submission":"PERINDOPRIL ERBUMINE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PERINDOPRIL ERBUMINE","submission":"PERINDOPRIL ERBUMINE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)