ANDA 087463

SPECGX LLC

FDA Drug Application

Application #087463

Application Sponsors

ANDA 087463

SPECGX LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;5MG

0

OXYCET

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1983-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-05-20
LABELING; Labeling	SUPPL	11	AP	1991-12-16
LABELING; Labeling	SUPPL	12	AP	1992-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1997-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-12-17
LABELING; Labeling	SUPPL	18	AP	1997-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-03-11
LABELING; Labeling	SUPPL	20	AP	1999-03-11
LABELING; Labeling	SUPPL	24	AP	2003-01-09
LABELING; Labeling	SUPPL	29	AP	2004-10-25
LABELING; Labeling	SUPPL	30	AP	2007-07-23
LABELING; Labeling	SUPPL	34	AP	2011-06-28
LABELING; Labeling	SUPPL	36	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	38	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	39	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	42	AP	2018-09-18
LABELING; Labeling	SUPPL	43	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	45	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	49	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	34	Null	7
SUPPL	36	Null	31
SUPPL	38	Null	7
SUPPL	39	Null	15
SUPPL	42	Null	7
SUPPL	43	Null	7
SUPPL	45	Null	7
SUPPL	49	Null	7

TE Codes

001

Prescription

AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87463
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCET","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCET","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)