ANDA 074128

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #074128

Application Sponsors

ANDA 074128

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

0.05%

0

CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE

FDA Submissions

	ORIG	1	AP	1994-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-06-28
LABELING; Labeling	SUPPL	8	AP	1998-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-08-29
LABELING; Labeling	SUPPL	13	AP	2002-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-05-30
LABELING; Labeling	SUPPL	16	AP	2004-05-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74128
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOBETASOL PROPIONATE","submission":"CLOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)