ANDA 077298

ACTAVIS LABS FL INC

FDA Drug Application

Application #077298

Application Sponsors

ANDA 077298

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	0	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG TARTRATE	0	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE

FDA Submissions

	ORIG	1	AP	2010-04-15
LABELING; Labeling	SUPPL	16	AP	2015-06-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	16	Null	7

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77298
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 100MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 200MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOPROLOL SUCCINATE","submission":"METOPROLOL SUCCINATE","actionType":"EQ 100MG TARTRATE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL SUCCINATE","submission":"METOPROLOL SUCCINATE","actionType":"EQ 200MG TARTRATE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)