ANDA 085868

SUN PHARM INDS LTD

FDA Drug Application

Application #085868

Application Sponsors

ANDA 085868

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG;30MG

0

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1978-11-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1982-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1982-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1987-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1982-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1985-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1987-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1987-02-06
LABELING; Labeling	SUPPL	37	AP	1988-08-25
LABELING; Labeling	SUPPL	38	AP	1989-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1995-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1995-01-09
LABELING; Labeling	SUPPL	41	AP	1995-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1995-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2000-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2002-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2002-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2002-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2002-09-05
LABELING; Labeling	SUPPL	54	AP	2007-10-18
LABELING; Labeling	SUPPL	55	AP	2008-06-05
LABELING; Labeling	SUPPL	56	AP	2011-06-23
LABELING; Labeling	SUPPL	57	AP	2013-05-14	STANDARD
LABELING; Labeling	SUPPL	58	AP	2014-03-20	STANDARD
LABELING; Labeling	SUPPL	59	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	60	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	61	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	62	AP	2017-08-29	STANDARD
REMS; REMS	SUPPL	63	AP	2018-09-18
LABELING; Labeling	SUPPL	64	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	65	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	66	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	25	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	56	Null	7
SUPPL	57	Null	7
SUPPL	58	Null	7
SUPPL	59	Null	15
SUPPL	60	Null	15
SUPPL	61	Null	15
SUPPL	62	Null	7
SUPPL	63	Null	7
SUPPL	64	Null	7
SUPPL	65	Null	7
SUPPL	66	Null	7

TE Codes

001

Prescription

AA

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85868
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)