ANDA 087006

WOCKHARDT BIO AG

FDA Drug Application

Application #087006

Documents

• Other: 2018-05-01

Application Sponsors

ANDA 087006

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

120MG/5ML;12MG/5ML

0

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1981-07-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-02-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-04-27
LABELING; Labeling	SUPPL	17	AP	1989-09-15
LABELING; Labeling	SUPPL	18	AP	1991-09-03
LABELING; Labeling	SUPPL	19	AP	1992-03-03
LABELING; Labeling	SUPPL	20	AP	1993-12-20
LABELING; Labeling	SUPPL	21	AP	1998-02-09
LABELING; Labeling	SUPPL	23	AP	2005-05-17
LABELING; Labeling	SUPPL	24	AP	2007-09-21
LABELING; Labeling	SUPPL	25	AP	2007-12-12
LABELING; Labeling	SUPPL	26	AP	2011-06-23
LABELING; Labeling	SUPPL	27	AP	2013-07-30	STANDARD
LABELING; Labeling	SUPPL	28	AP	2014-03-20	STANDARD
LABELING; Labeling	SUPPL	30	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	31	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	32	AP	2018-02-07	STANDARD
REMS; REMS	SUPPL	33	AP	2018-09-18
LABELING; Labeling	SUPPL	34	AP	2018-09-18	STANDARD
LABELING; Labeling	SUPPL	36	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	39	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0
SUPPL	26	Null	7
SUPPL	27	Null	15
SUPPL	28	Null	15
SUPPL	30	Null	15
SUPPL	31	Null	7
SUPPL	32	Null	7
SUPPL	33	Null	7
SUPPL	34	Null	15
SUPPL	36	Null	7
SUPPL	39	Null	7

TE Codes

001

Prescription

AA

CDER Filings

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            [ApplNo] => 87006
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            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)