ANDA 089124

TARO

FDA Drug Application

Application #089124

Application Sponsors

ANDA 089124

TARO

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

0.01%

0

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1985-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-10-07
LABELING; Labeling	SUPPL	6	AP	1988-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1990-01-03
LABELING; Labeling	SUPPL	12	AP	1991-03-18
LABELING; Labeling	SUPPL	13	AP	1992-11-02
LABELING; Labeling	SUPPL	14	AP	1993-03-29
LABELING; Labeling	SUPPL	15	AP	1996-07-31

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0

TE Codes

001

Prescription

AT

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89124
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINOLONE ACETONIDE","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.01%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOCINOLONE ACETONIDE","submission":"FLUOCINOLONE ACETONIDE","actionType":"0.01%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)