NDA 018586

TARO PHARM INDS LTD

FDA Drug Application

Application #018586

Documents

• Letter: 2004-04-29
• Label: 2004-05-04

Application Sponsors

NDA 018586

TARO PHARM INDS LTD

Marketing Status

• Discontinued: 001

Application Products

001

GEL;TOPICAL

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

TOPICORT

DESOXIMETASONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1982-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-09-25	STANDARD
LABELING; Labeling	SUPPL	4	AP	2004-04-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1993-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-09-15	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18586
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPICORT","activeIngredients":"DESOXIMETASONE","strength":"0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"GEL;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/27\/2004","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/18586slr004_topicort_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TOPICORT","submission":"DESOXIMETASONE","actionType":"0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"GEL;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2004-04-27
        )

)