ANDA 087408

AM REGENT

FDA Drug Application

Application #087408

Application Sponsors

ANDA 087408

AM REGENT

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	25MG/ML	0	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	50MG/ML	0	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1981-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-05-22
LABELING; Labeling	SUPPL	9	AP	1991-09-04
LABELING; Labeling	SUPPL	10	AP	1992-04-02
LABELING; Labeling	SUPPL	11	AP	1992-12-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-07-17
LABELING; Labeling	SUPPL	15	AP	2003-01-02
LABELING; Labeling	SUPPL	22	AP	2014-06-03	STANDARD
LABELING; Labeling	SUPPL	25	AP	2016-03-30	STANDARD
LABELING; Labeling	SUPPL	26	AP	2016-11-08	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	22	Null	15
SUPPL	25	Null	7
SUPPL	26	Null	7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87408
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)