ANDA 087794

SUN PHARM INDUSTRIES

FDA Drug Application

Application #087794

Application Sponsors

ANDA 087794

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

325MG;4.5MG;0.38MG

0

OXYCODONE AND ASPIRIN

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

FDA Submissions

	ORIG	1	AP	1982-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-03-31
LABELING; Labeling	SUPPL	12	AP	1989-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-07-14
LABELING; Labeling	SUPPL	14	AP	1990-01-30
LABELING; Labeling	SUPPL	15	AP	1990-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1991-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-12-01
LABELING; Labeling	SUPPL	24	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	25	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	26	AP	2017-03-07	STANDARD
REMS; REMS	SUPPL	27	AP	2018-09-18
LABELING; Labeling	SUPPL	28	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	29	AP	2019-10-09	STANDARD
LABELING; Labeling	SUPPL	30	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	31	AP	2021-05-04	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	15
SUPPL	25	Null	7
SUPPL	26	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	15
SUPPL	29	Null	15
SUPPL	30	Null	7
SUPPL	31	Null	7

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87794
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ASPIRIN","activeIngredients":"ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE","strength":"325MG;4.5MG;0.38MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE AND ASPIRIN","submission":"ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE","actionType":"325MG;4.5MG;0.38MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)