ANDA 090707

VISTAPHARM

FDA Drug Application

Application #090707

Documents

• Other: 2015-06-30
• Label: 2014-05-06

Application Sponsors

ANDA 090707

VISTAPHARM

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;ORAL	5MG/5ML	0	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE
002	SOLUTION;ORAL	10MG/5ML	0	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-06-30
REMS; REMS	SUPPL	2	AP	2013-04-15
LABELING; Labeling	SUPPL	3	AP	2014-04-16	STANDARD
REMS; REMS	SUPPL	5	AP	2014-08-19
REMS; REMS	SUPPL	6	AP	2015-06-26
REMS; REMS	SUPPL	7	AP	2016-04-20
LABELING; Labeling	SUPPL	8	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	10	AP	2016-09-30
LABELING; Labeling	SUPPL	11	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-01-23	STANDARD
REMS; REMS	SUPPL	13	AP	2017-05-26
LABELING; Labeling	SUPPL	14	AP	2018-01-31	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-01-31	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-02-01	STANDARD
REMS; REMS	SUPPL	17	AP	2018-09-18
LABELING; Labeling	SUPPL	18	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	24	AP	2021-06-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15
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	17	Null	7
SUPPL	18	Null	7
SUPPL	23	Null	7
SUPPL	24	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90707
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/16\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/090707Orig1s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/090707Orig1s003lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-04-16
        )

)