ANDA 074904

TARO PHARM INDS LTD

FDA Drug Application

Application #074904

Documents

• Letter: 1998-07-14
• Label: 2015-08-26
• Letter: 2015-08-27
• Review: 1998-07-14

Application Sponsors

ANDA 074904

TARO PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.05%

0

TOPICORT

DESOXIMETASONE

FDA Submissions

	ORIG	1	AP	1998-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-11-04
LABELING; Labeling	SUPPL	5	AP	2003-07-24
LABELING; Labeling	SUPPL	7	AP	2003-12-19
LABELING; Labeling	SUPPL	8	AP	2004-11-23
LABELING; Labeling	SUPPL	15	AP	2012-01-05

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	15	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74904
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPICORT","activeIngredients":"DESOXIMETASONE","strength":"0.05%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/05\/2012","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/074904Orig1s015Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TOPICORT","submission":"DESOXIMETASONE","actionType":"0.05%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-01-05
        )

)