ANDA 076307

ACTAVIS LABS FL INC

FDA Drug Application

Application #076307

Documents

• Other Important Information from FDA: 2005-08-01

Application Sponsors

ANDA 076307

ACTAVIS LABS FL INC

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2003-12-17
LABELING; Labeling	SUPPL	2	AP	2006-02-28
LABELING; Labeling	SUPPL	4	AP	2004-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2006-02-28
LABELING; Labeling	SUPPL	6	AP	2006-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2006-02-28
LABELING; Labeling	SUPPL	8	AP	2005-07-14
LABELING; Labeling	SUPPL	11	AP	2007-11-07
LABELING; Labeling	SUPPL	14	AP	2007-11-07
LABELING; Labeling	SUPPL	20	AP	2020-02-25	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-02-25	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	20	Null	7
SUPPL	22	Null	7

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76307
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"30MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"45MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"15MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"30MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"45MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)