ANDA 088229

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #088229

Application Sponsors

ANDA 088229

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

CONCENTRATE;ORAL

100MG/ML

0

THIORIDAZINE HYDROCHLORIDE

THIORIDAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1983-08-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-09-03
LABELING; Labeling	SUPPL	8	AP	1989-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-11-20
LABELING; Labeling	SUPPL	18	AP	2001-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-07-24
LABELING; Labeling	SUPPL	24	AP	2015-11-03
LABELING; Labeling	SUPPL	25	AP	2017-02-23	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	24	Null	7
SUPPL	25	Null	15

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88229
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"100MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)