ANDA 040545

SPECGX LLC

FDA Drug Application

Application #040545

Application Sponsors

ANDA 040545

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	325MG;7.5MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
002	TABLET;ORAL	325MG;10MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-06-30
LABELING; Labeling	SUPPL	2	AP	2004-10-25
LABELING; Labeling	SUPPL	3	AP	2007-07-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2008-01-26
LABELING; Labeling	SUPPL	7	AP	2011-06-28
LABELING; Labeling	SUPPL	9	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	15	AP	2018-09-18
LABELING; Labeling	SUPPL	16	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	21	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	7	Null	7
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	7
SUPPL	21	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40545
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)