ANDA 085883

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #085883

Application Sponsors

ANDA 085883

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

120MG/5ML;12MG/5ML

0

CAPITAL AND CODEINE

ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1979-01-08
LABELING; Labeling	SUPPL	11	AP	1989-11-02
LABELING; Labeling	SUPPL	16	AP	1989-11-02
LABELING; Labeling	SUPPL	17	AP	1990-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1992-12-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1991-10-08
LABELING; Labeling	SUPPL	21	AP	1994-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1994-09-22
LABELING; Labeling	SUPPL	23	AP	1996-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1996-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2000-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2001-09-07
LABELING; Labeling	SUPPL	37	AP	2011-06-22
LABELING; Labeling	SUPPL	38	AP	2015-11-04	STANDARD
LABELING; Labeling	SUPPL	40	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	41	AP	2016-12-16	STANDARD

Submissions Property Types

SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	37	Null	7
SUPPL	38	Null	7
SUPPL	40	Null	7
SUPPL	41	Null	7

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85883
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAPITAL AND CODEINE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"120MG\/5ML;12MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CAPITAL AND CODEINE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"120MG\/5ML;12MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)