NDA 018613

TARO PHARM INDS LTD

FDA Drug Application

Application #018613

Documents

• Letter: 2011-12-14
• Label: 2003-04-04
• Label: 2011-12-14
• Letter: 2003-04-16
• Review: 1999-04-30
• Review: 1999-04-30

Application Sponsors

NDA 018613

TARO PHARM INDS LTD

Marketing Status

• Discontinued: 001

Application Products

001

LOTION;TOPICAL

0.5%

1

OVIDE

MALATHION

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1982-08-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-05-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	1989-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-04-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	1999-04-30	STANDARD
LABELING; Labeling	SUPPL	11	AP	2003-04-04	STANDARD
LABELING; Labeling	SUPPL	17	AP	2011-12-09	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	9	Null	0
SUPPL	17	Null	15

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18613
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OVIDE","activeIngredients":"MALATHION","strength":"0.5%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/09\/2011","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018613s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2003","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/018613s011lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OVIDE","submission":"MALATHION","actionType":"0.5%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-12-09
        )

)