ANDA 076336

ACTAVIS LABS FL INC

FDA Drug Application

Application #076336

Documents

• Other Important Information from FDA: 2005-12-13

Application Sponsors

ANDA 076336

ACTAVIS LABS FL INC

Marketing Status

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

Application Products

001	TABLET;ORAL	15MG	0	MIRTAZAPINE	MIRTAZAPINE
002	TABLET;ORAL	30MG	0	MIRTAZAPINE	MIRTAZAPINE
003	TABLET;ORAL	45MG	0	MIRTAZAPINE	MIRTAZAPINE

FDA Submissions

	ORIG	1	AP	2003-06-20
LABELING; Labeling	SUPPL	3	AP	2005-04-28
LABELING; Labeling	SUPPL	5	AP	2005-04-28
LABELING; Labeling	SUPPL	6	AP	2006-11-06
LABELING; Labeling	SUPPL	7	AP	2007-11-05

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76336
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"45MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"45MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)