NDA 208183

SUN PHARM INDUSTRIES

FDA Drug Application

Application #208183

Documents

• Review: 2016-06-29
• Summary Review: 2016-06-29
• Letter: 2015-11-13
• Label: 2015-11-12
• Letter: 2020-08-28
• Label: 2020-09-04

Application Sponsors

NDA 208183

SUN PHARM INDUSTRIES

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.05%

1

ULTRAVATE

HALOBETASOL PROPIONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2015-11-06	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2020-08-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDUSTRIES

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(
    [0] => Array
        (
            [ApplNo] => 208183
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTRAVATE","activeIngredients":"HALOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/27\/2020","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208183s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/208183s000lbl.pdf\"}]","notes":""}]
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            [supplements] => [{"actionDate":"08\/27\/2020","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208183s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208183Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-08-27
        )

)