ANDA 040241

VISTAPHARM

FDA Drug Application

Application #040241

Documents

• Review: 2004-06-09
• Letter: 2004-06-09
• Other: 2015-06-30

Application Sponsors

ANDA 040241

VISTAPHARM

Marketing Status

• Discontinued: 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	1998-05-29
LABELING; Labeling	SUPPL	4	AP	2007-02-05
REMS; REMS	SUPPL	6	AP	2012-07-09
LABELING; Labeling	SUPPL	7	AP	2012-07-09
REMS; REMS	SUPPL	8	AP	2013-04-15
LABELING; Labeling	SUPPL	9	AP	2014-12-19	STANDARD
REMS; REMS	SUPPL	11	AP	2014-08-19
REMS; REMS	SUPPL	12	AP	2015-06-26
LABELING; Labeling	SUPPL	13	AP	2015-05-29	STANDARD
REMS; REMS	SUPPL	14	AP	2016-04-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2016-10-31	UNKNOWN
REMS; REMS	SUPPL	16	AP	2016-09-30
REMS; REMS	SUPPL	18	AP	2017-05-26
REMS; REMS	SUPPL	19	AP	2018-09-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15

TE Codes

002

Prescription

AA

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40241
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)