ANDA 087143

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #087143

Application Sponsors

ANDA 087143

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OTIC

2%;1%

0

ACETASOL HC

ACETIC ACID, GLACIAL; HYDROCORTISONE

FDA Submissions

	ORIG	1	AP	1982-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-12-15
LABELING; Labeling	SUPPL	7	AP	1990-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1992-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1992-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1993-11-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1998-10-26
LABELING; Labeling	SUPPL	19	AP	1998-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-12-29

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87143
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETASOL HC","activeIngredients":"ACETIC ACID, GLACIAL; HYDROCORTISONE","strength":"2%;1%","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETASOL HC","submission":"ACETIC ACID, GLACIAL; HYDROCORTISONE","actionType":"2%;1%","submissionClassification":"SOLUTION\/DROPS;OTIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)