ANDA 089674

PAR PHARM

FDA Drug Application

Application #089674

Application Sponsors

ANDA 089674

PAR PHARM

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1988-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-11-26
LABELING; Labeling	SUPPL	5	AP	1998-10-05

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89674
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)