ANDA 088734

PLIVA

FDA Drug Application

Application #088734

Application Sponsors

ANDA 088734

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-12-11
LABELING; Labeling	SUPPL	5	AP	1990-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-07-07

Submissions Property Types

SUPPL	1	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88734
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)