ANDA 074075

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #074075

Application Sponsors

ANDA 074075

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

EQ 0.5MG BASE/5ML

0

CLEMASTINE FUMARATE

CLEMASTINE FUMARATE

FDA Submissions

	ORIG	1	AP	1993-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-03-27
LABELING; Labeling	SUPPL	5	AP	2000-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-12-04

Submissions Property Types

SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74075
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEMASTINE FUMARATE","activeIngredients":"CLEMASTINE FUMARATE","strength":"EQ 0.5MG BASE\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLEMASTINE FUMARATE","submission":"CLEMASTINE FUMARATE","actionType":"EQ 0.5MG BASE\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)