ANDA 075082

VISTAPHARM

FDA Drug Application

Application #075082

Documents

• Review: 1999-03-22

Application Sponsors

ANDA 075082

VISTAPHARM

Marketing Status

• Prescription: 001

Application Products

001

TABLET, FOR SUSPENSION;ORAL

40MG

0

METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1998-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-02-02
LABELING; Labeling	SUPPL	5	AP	2007-12-14
LABELING; Labeling	SUPPL	6	AP	2015-08-17	STANDARD
REMS; REMS	SUPPL	8	AP	2018-09-18

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	7
SUPPL	8	Null	15

TE Codes

001

Prescription

AA

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75082
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET, FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)