NDA 018594

TARO PHARM INDS LTD

FDA Drug Application

Application #018594

Documents

• Letter: 2010-05-21
• Label: 2010-05-28
• Label: 2014-12-19
• Letter: 2014-12-11

Application Sponsors

NDA 018594

TARO PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

0.05%

1

TOPICORT

DESOXIMETASONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1985-01-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-07-26	STANDARD
LABELING; Labeling	SUPPL	7	AP	2010-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2012-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2014-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2014-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2014-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2015-11-06	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	7
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18594
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPICORT","activeIngredients":"DESOXIMETASONE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/07\/2012","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/018594Orig1s008lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/14\/2010","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018594s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TOPICORT","submission":"DESOXIMETASONE","actionType":"0.05%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-12-07
        )

)