ANDA 074184

SPECGX LLC

FDA Drug Application

Application #074184

Documents

• Other Important Information from FDA: 2006-11-27

Application Sponsors

ANDA 074184

SPECGX LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, FOR SUSPENSION;ORAL

40MG

0

METHADOSE

METHADONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1993-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-11-28
LABELING; Labeling	SUPPL	10	AP	2006-03-23
LABELING; Labeling	SUPPL	11	AP	2007-04-04
LABELING; Labeling	SUPPL	12	AP	2009-11-09
LABELING; Labeling	SUPPL	16	AP	2014-12-13	STANDARD
REMS; REMS	SUPPL	22	AP	2018-09-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	12	Null	7
SUPPL	16	Null	15
SUPPL	22	Null	7

TE Codes

001

Prescription

AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74184
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADOSE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHADOSE","submission":"METHADONE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET, FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)