ANDA 087146

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #087146

Application Sponsors

ANDA 087146

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OTIC

2%

0

ACETASOL

ACETIC ACID, GLACIAL

FDA Submissions

	ORIG	1	AP	1981-08-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-09-15
LABELING; Labeling	SUPPL	8	AP	1989-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1992-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1993-11-17
LABELING; Labeling	SUPPL	15	AP	1998-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-12-29

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87146
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETASOL","activeIngredients":"ACETIC ACID, GLACIAL","strength":"2%","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETASOL","submission":"ACETIC ACID, GLACIAL","actionType":"2%","submissionClassification":"SOLUTION\/DROPS;OTIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)