ANDA 040579

PRINSTON INC

FDA Drug Application

Application #040579

Application Sponsors

ANDA 040579

PRINSTON INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-05-27
LABELING; Labeling	SUPPL	4	AP	2013-04-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-06-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-03-30	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-11-08	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	7	Null	15
SUPPL	10	Null	15
SUPPL	13	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40579
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)