ANDA 040580

PRINSTON INC

FDA Drug Application

Application #040580

Application Sponsors

ANDA 040580

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

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

FDA Submissions

	ORIG	1	AP	2005-05-27
LABELING; Labeling	SUPPL	5	AP	2013-04-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-06-04	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-03-30	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-11-08	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	7
SUPPL	14	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40580
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)