ANDA 074512

L PERRIGO CO

FDA Drug Application

Application #074512

Application Sponsors

ANDA 074512

L PERRIGO CO

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

1.34MG

0

CLEMASTINE FUMARATE

CLEMASTINE FUMARATE

FDA Submissions

	ORIG	1	AP	1995-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-07-09
LABELING; Labeling	SUPPL	3	AP	2000-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-03-23
LABELING; Labeling	SUPPL	6	AP	2002-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-12-13

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74512
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEMASTINE FUMARATE","activeIngredients":"CLEMASTINE FUMARATE","strength":"1.34MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLEMASTINE FUMARATE","submission":"CLEMASTINE FUMARATE","actionType":"1.34MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)