ANDA 073193

TARO PHARM INDS LTD

FDA Drug Application

Application #073193

Documents

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

Application Sponsors

ANDA 073193

TARO PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.25%

0

TOPICORT

DESOXIMETASONE

FDA Submissions

	ORIG	1	AP	1990-11-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-05-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-06-20
LABELING; Labeling	SUPPL	20	AP	2003-12-19
LABELING; Labeling	SUPPL	21	AP	2004-02-19
LABELING; Labeling	SUPPL	22	AP	2004-11-23
LABELING; Labeling	SUPPL	27	AP	2008-02-29
LABELING; Labeling	SUPPL	33	AP	2012-01-03

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	33	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARM INDS LTD

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(
    [0] => Array
        (
            [ApplNo] => 73193
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPICORT","activeIngredients":"DESOXIMETASONE","strength":"0.25%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/03\/2012","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/073193SOrig1s33Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TOPICORT","submission":"DESOXIMETASONE","actionType":"0.25%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-01-03
        )

)