ANDA 078730

ANI PHARMS INC

FDA Drug Application

Application #078730

Documents

• Review: 2013-02-01

Application Sponsors

ANDA 078730

ANI PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	15MG	0	LANSOPRAZOLE	LANSOPRAZOLE
002	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	30MG	0	LANSOPRAZOLE	LANSOPRAZOLE

FDA Submissions

ORIG

1

AP

2010-10-15

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78730
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LANSOPRAZOLE","submission":"LANSOPRAZOLE","actionType":"15MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LANSOPRAZOLE","submission":"LANSOPRAZOLE","actionType":"30MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)