ANDA 073210

TARO PHARM INDS LTD

FDA Drug Application

Application #073210

Documents

• Letter: 2015-08-27
• Label: 2015-08-26

Application Sponsors

ANDA 073210

TARO PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

TOPICORT

DESOXIMETASONE

FDA Submissions

	ORIG	1	AP	1990-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-05-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-06-20
LABELING; Labeling	SUPPL	15	AP	2003-12-19
LABELING; Labeling	SUPPL	16	AP	2004-02-19
LABELING; Labeling	SUPPL	17	AP	2004-11-23
LABELING; Labeling	SUPPL	27	AP	2011-12-30
LABELING; Labeling	SUPPL	29	AP	2012-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2014-06-19	UNKNOWN

Submissions Property Types

SUPPL	2	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	27	Null	7
SUPPL	29	Null	15
SUPPL	31	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73210
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPICORT","activeIngredients":"DESOXIMETASONE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/11\/2012","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/073210Orig1s029Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TOPICORT","submission":"DESOXIMETASONE","actionType":"0.05%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-01-11
        )

)