ANDA 040050

SPECGX LLC

FDA Drug Application

Application #040050

Documents

• Other Important Information from FDA: 2006-11-27
• Other: 2015-06-30

Application Sponsors

ANDA 040050

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	METHADOSE	METHADONE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	METHADOSE	METHADONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1993-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-11-14
LABELING; Labeling	SUPPL	10	AP	2007-01-10
REMS; REMS	SUPPL	12	AP	2012-07-09
LABELING; Labeling	SUPPL	13	AP	2012-07-09
REMS; REMS	SUPPL	14	AP	2013-04-15
LABELING; Labeling	SUPPL	16	AP	2014-07-23	STANDARD
REMS; REMS	SUPPL	18	AP	2014-08-19
REMS; REMS	SUPPL	19	AP	2015-06-26
LABELING; Labeling	SUPPL	20	AP	2015-06-01	STANDARD
REMS; REMS	SUPPL	21	AP	2016-04-20
REMS; REMS	SUPPL	22	AP	2016-09-30
REMS; REMS	SUPPL	24	AP	2017-05-26
LABELING; Labeling	SUPPL	25	AP	2022-11-23	STANDARD
LABELING; Labeling	SUPPL	26	AP	2022-11-23	STANDARD
REMS; REMS	SUPPL	27	AP	2018-09-18
LABELING; Labeling	SUPPL	28	AP	2022-11-23	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-11-23	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	7
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	7
SUPPL	22	Null	15
SUPPL	24	Null	31
SUPPL	25	Null	7
SUPPL	26	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	7
SUPPL	29	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40050
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADOSE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHADOSE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHADOSE","submission":"METHADONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHADOSE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)