ANDA 087083

SUN PHARM INDS LTD

FDA Drug Application

Application #087083

Application Sponsors

ANDA 087083

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG;60MG

0

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1980-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1986-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1987-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1987-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1987-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1987-02-06
LABELING; Labeling	SUPPL	24	AP	1988-08-25
LABELING; Labeling	SUPPL	25	AP	1989-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1995-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1995-01-09
LABELING; Labeling	SUPPL	28	AP	1995-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1995-01-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2000-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2002-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2002-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2002-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2002-09-03
LABELING; Labeling	SUPPL	41	AP	2007-10-18
LABELING; Labeling	SUPPL	42	AP	2008-06-05
LABELING; Labeling	SUPPL	43	AP	2011-06-23
LABELING; Labeling	SUPPL	44	AP	2013-05-14	STANDARD
LABELING; Labeling	SUPPL	45	AP	2014-03-20	STANDARD
LABELING; Labeling	SUPPL	46	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	47	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	48	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	49	AP	2017-08-29	STANDARD
REMS; REMS	SUPPL	50	AP	2018-09-18
LABELING; Labeling	SUPPL	51	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	52	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	53	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	43	Null	7
SUPPL	44	Null	15
SUPPL	45	Null	7
SUPPL	46	Null	7
SUPPL	47	Null	7
SUPPL	48	Null	15
SUPPL	49	Null	15
SUPPL	50	Null	7
SUPPL	51	Null	7
SUPPL	52	Null	7
SUPPL	53	Null	15

TE Codes

001

Prescription

AA

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87083
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)