ANDA 040680

SPECGX LLC

FDA Drug Application

Application #040680

Application Sponsors

ANDA 040680

SPECGX LLC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

325MG/5ML;5MG/5ML

0

OXYCODONE AND ACETAMINOPHEN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-09-29
LABELING; Labeling	SUPPL	2	AP	2013-10-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-12-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	11	AP	2018-09-18
LABELING; Labeling	SUPPL	12	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-10-08	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	8	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7
SUPPL	14	Null	7

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40680
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG\/5ML;5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"325MG\/5ML;5MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)