ANDA 076995

ACTAVIS LABS FL INC

FDA Drug Application

Application #076995

Application Sponsors

ANDA 076995

ACTAVIS LABS FL INC

Marketing Status

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

Application Products

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

FDA Submissions

ORIG

1

AP

2010-04-26

Submissions Property Types

ORIG

1

Null

42

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76995
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)