ANDA 040088

VISTAPHARM

FDA Drug Application

Application #040088

Application Sponsors

ANDA 040088

VISTAPHARM

Marketing Status

• Prescription: 001

Application Products

001

CONCENTRATE;ORAL

10MG/ML

0

METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1994-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-09-27
LABELING; Labeling	SUPPL	3	AP	2002-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2011-10-21
LABELING; Labeling	SUPPL	10	AP	2022-12-14	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-12-14	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-12-14	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-12-14	STANDARD
LABELING; Labeling	SUPPL	20	AP	2022-12-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	8	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	15	Null	7
SUPPL	18	Null	7
SUPPL	20	Null	7

TE Codes

001

Prescription

AA

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40088
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)