ANDA 089381

SUN PHARM INDUSTRIES

FDA Drug Application

Application #089381

Application Sponsors

ANDA 089381

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1986-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-06-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-04-03
LABELING; Labeling	SUPPL	12	AP	2002-03-12
LABELING; Labeling	SUPPL	23	AP	2006-07-21
LABELING; Labeling	SUPPL	30	AP	2014-06-03	STANDARD
LABELING; Labeling	SUPPL	34	AP	2016-03-30	STANDARD
LABELING; Labeling	SUPPL	35	AP	2016-11-08	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	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	10	Null	0
SUPPL	11	Null	0
SUPPL	30	Null	7
SUPPL	34	Null	7
SUPPL	35	Null	7

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89381
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)