ANDA 072494

TARO PHARM INDS LTD

FDA Drug Application

Application #072494

Application Sponsors

ANDA 072494

TARO PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

FLUOCINONIDE EMULSIFIED BASE

FLUOCINONIDE

FDA Submissions

	ORIG	1	AP	1989-01-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-05-15
LABELING; Labeling	SUPPL	3	AP	1995-10-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-09-13
LABELING; Labeling	SUPPL	7	AP	2004-04-13

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

TE Codes

001

Prescription

AB2

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72494
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINONIDE EMULSIFIED BASE","activeIngredients":"FLUOCINONIDE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOCINONIDE EMULSIFIED BASE","submission":"FLUOCINONIDE","actionType":"0.05%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)