NDA 204141

TARO PHARMS

FDA Drug Application

Application #204141

Documents

• Label: 2015-12-17
• Review: 2013-11-05
• Letter: 2013-04-16
• Letter: 2015-12-17
• Label: 2013-04-16
• Summary Review: 2013-11-05
• Letter: 2021-10-12
• Label: 2021-10-13

Application Sponsors

NDA 204141

TARO PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SPRAY;TOPICAL

0.25%

1

TOPICORT

DESOXIMETASONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2013-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-09-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-12-16	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2021-10-07	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	15
SUPPL	9	Null	15

TE Codes

001

Prescription

AT

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204141
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPICORT","activeIngredients":"DESOXIMETASONE","strength":"0.25%","dosageForm":"SPRAY;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/16\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204141s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204141s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/11\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204141s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204141Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204141_topicort_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204141Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/16\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204141s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204141Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/23\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/10\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/18\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-16
        )

)