NDA 010485

ROERIG

FDA Drug Application

Application #010485

Documents

• Letter: 2001-03-21

Application Sponsors

NDA 010485

ROERIG

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

ATARAX

HYDROXYZINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1956-05-31	STANDARD
LABELING; Labeling	SUPPL	11	AP	1979-05-21
LABELING; Labeling	SUPPL	16	AP	1985-05-20
LABELING; Labeling	SUPPL	18	AP	2001-03-21	STANDARD

CDER Filings

ROERIG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10485
            [companyName] => ROERIG
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATARAX","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"10MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATARAX","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"10MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)