ANDA 085269

ANI PHARMS INC

FDA Drug Application

Application #085269

Application Sponsors

ANDA 085269

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

12.5MG

0

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-11-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1987-09-14
LABELING; Labeling	SUPPL	19	AP	1988-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1989-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-06-15

Submissions Property Types

SUPPL	4	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0

CDER Filings

ANI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85269
            [companyName] => ANI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)