ANDA 087102

TARO

FDA Drug Application

Application #087102

Application Sponsors

ANDA 087102

TARO

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

0.01%

0

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1982-04-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-01-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-10-07
LABELING; Labeling	SUPPL	18	AP	1988-11-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1992-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1990-01-03
LABELING; Labeling	SUPPL	21	AP	1989-09-19
LABELING; Labeling	SUPPL	23	AP	1991-01-07
LABELING; Labeling	SUPPL	24	AP	1991-03-15
LABELING; Labeling	SUPPL	26	AP	1992-11-16
LABELING; Labeling	SUPPL	27	AP	1993-03-29
LABELING; Labeling	SUPPL	28	AP	1993-03-29
LABELING; Labeling	SUPPL	29	AP	1996-07-31

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87102
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINOLONE ACETONIDE","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.01%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOCINOLONE ACETONIDE","submission":"FLUOCINOLONE ACETONIDE","actionType":"0.01%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)