ANDA 087862

SUN PHARM INDUSTRIES

FDA Drug Application

Application #087862

Application Sponsors

ANDA 087862

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1983-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-12-01
LABELING; Labeling	SUPPL	15	AP	2014-06-03	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-03-30	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-11-08	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87862
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)