ANDA 085861

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #085861

Application Sponsors

ANDA 085861

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

120MG/5ML;12MG/5ML

0

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1978-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-12-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1985-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1987-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1986-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1986-12-19
LABELING; Labeling	SUPPL	18	AP	1990-05-18
LABELING; Labeling	SUPPL	19	AP	1988-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1989-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1989-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1990-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1990-09-14
LABELING; Labeling	SUPPL	25	AP	1989-03-16
LABELING; Labeling	SUPPL	26	AP	1990-05-18
LABELING; Labeling	SUPPL	28	AP	1990-05-18
LABELING; Labeling	SUPPL	29	AP	1990-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1992-04-06
LABELING; Labeling	SUPPL	33	AP	1990-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1991-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1993-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1993-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1993-07-16
LABELING; Labeling	SUPPL	41	AP	1993-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1994-09-22
LABELING; Labeling	SUPPL	43	AP	1994-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1997-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2000-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2001-04-02
LABELING; Labeling	SUPPL	68	AP	2008-06-27
LABELING; Labeling	SUPPL	69	AP	2011-06-22
LABELING; Labeling	SUPPL	70	AP	2015-11-04	STANDARD
LABELING; Labeling	SUPPL	71	AP	2017-02-14	STANDARD
LABELING; Labeling	SUPPL	72	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	73	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	74	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	75	AP	2018-01-30	STANDARD
LABELING; Labeling	SUPPL	76	AP	2018-09-20	STANDARD
REMS; REMS	SUPPL	77	AP	2018-09-18
LABELING; Labeling	SUPPL	78	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	79	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	30	Null	0
SUPPL	35	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	44	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	69	Null	7
SUPPL	70	Null	7
SUPPL	71	Null	7
SUPPL	72	Null	15
SUPPL	73	Null	15
SUPPL	74	Null	15
SUPPL	75	Null	7
SUPPL	76	Null	7
SUPPL	77	Null	15
SUPPL	78	Null	15
SUPPL	79	Null	15

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85861
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"120MG\/5ML;12MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"120MG\/5ML;12MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)