ANDA 087104

TARO

FDA Drug Application

Application #087104

Application Sponsors

ANDA 087104

TARO

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.025%

0

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1982-04-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-12-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1986-10-07
LABELING; Labeling	SUPPL	20	AP	1989-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1990-01-03
LABELING; Labeling	SUPPL	23	AP	1990-01-19
LABELING; Labeling	SUPPL	24	AP	1991-02-11
LABELING; Labeling	SUPPL	25	AP	1991-02-11
LABELING; Labeling	SUPPL	27	AP	1992-11-16
LABELING; Labeling	SUPPL	28	AP	1993-03-29
LABELING; Labeling	SUPPL	30	AP	1996-07-31

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	21	Null	0

TE Codes

001

Prescription

AT

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87104
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINOLONE ACETONIDE","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.025%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOCINOLONE ACETONIDE","submission":"FLUOCINOLONE ACETONIDE","actionType":"0.025%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)