ANDA 040517

SPECGX LLC

FDA Drug Application

Application #040517

Documents

• Other: 2015-06-30

Application Sponsors

ANDA 040517

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	2004-04-27
LABELING; Labeling	SUPPL	2	AP	2006-03-02
LABELING; Labeling	SUPPL	3	AP	2007-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2008-01-26
REMS; REMS	SUPPL	7	AP	2012-07-09
LABELING; Labeling	SUPPL	8	AP	2012-07-09
REMS; REMS	SUPPL	9	AP	2013-04-15
LABELING; Labeling	SUPPL	12	AP	2014-07-23	STANDARD
REMS; REMS	SUPPL	14	AP	2014-08-19
REMS; REMS	SUPPL	15	AP	2015-06-26
LABELING; Labeling	SUPPL	16	AP	2015-06-01	STANDARD
REMS; REMS	SUPPL	18	AP	2016-04-20
LABELING; Labeling	SUPPL	19	AP	2016-10-28	STANDARD
REMS; REMS	SUPPL	20	AP	2016-09-30
REMS; REMS	SUPPL	22	AP	2017-05-26
LABELING; Labeling	SUPPL	23	AP	2022-03-16	STANDARD
LABELING; Labeling	SUPPL	24	AP	2022-03-16	STANDARD
REMS; REMS	SUPPL	25	AP	2018-09-18
LABELING; Labeling	SUPPL	26	AP	2022-03-16	STANDARD
LABELING; Labeling	SUPPL	28	AP	2022-03-16	STANDARD
LABELING; Labeling	SUPPL	30	AP	2021-06-02	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	7	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	7
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	26	Null	7
SUPPL	28	Null	15
SUPPL	30	Null	15

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40517
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)