ANDA 087871

AUROLIFE PHARMA LLC

FDA Drug Application

Application #087871

Application Sponsors

ANDA 087871

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	50MG	0	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE
003	TABLET;ORAL	25MG	0	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1982-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1985-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1988-04-25
LABELING; Labeling	SUPPL	20	AP	1988-11-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1995-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2000-01-10
LABELING; Labeling	SUPPL	26	AP	2014-06-03	STANDARD
LABELING; Labeling	SUPPL	27	AP	2016-03-30	STANDARD
LABELING; Labeling	SUPPL	28	AP	2016-11-08	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	26	Null	15
SUPPL	27	Null	7
SUPPL	28	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87871
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)