ANDA 088461

SUN PHARM INDUSTRIES

FDA Drug Application

Application #088461

Application Sponsors

ANDA 088461

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

15MG

0

THIORIDAZINE HYDROCHLORIDE

THIORIDAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1983-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-10-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-03-03
LABELING; Labeling	SUPPL	11	AP	1988-06-02
LABELING; Labeling	SUPPL	12	AP	1988-08-19
LABELING; Labeling	SUPPL	14	AP	1990-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-12-01
LABELING; Labeling	SUPPL	21	AP	2010-12-03
LABELING; Labeling	SUPPL	22	AP	2017-02-23	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	7
SUPPL	22	Null	15

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88461
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)