ANDA 077142

SPECGX LLC

FDA Drug Application

Application #077142

Application Sponsors

ANDA 077142

SPECGX LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, FOR SUSPENSION;ORAL

40MG

0

METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-07-12
LABELING; Labeling	SUPPL	2	AP	2006-09-20
LABELING; Labeling	SUPPL	3	AP	2006-03-23
LABELING; Labeling	SUPPL	5	AP	2007-04-04
LABELING; Labeling	SUPPL	6	AP	2009-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-11-05
LABELING; Labeling	SUPPL	11	AP	2014-12-13	STANDARD
REMS; REMS	SUPPL	17	AP	2018-09-18

Submissions Property Types

SUPPL	6	Null	7
SUPPL	8	Null	0
SUPPL	11	Null	7
SUPPL	17	Null	15

TE Codes

001

Prescription

AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77142
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET, FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)