BLA 125516

UNITED THERAP

FDA Drug Application

Application #125516

Documents

• Letter: 2015-03-10
• Label: 2015-03-10
• Review: 2015-04-09
• Summary Review: 2015-04-09
• Label: 2017-03-02
• Letter: 2017-03-03
• Letter: 2020-09-30
• Label: 2020-10-01

Application Sponsors

BLA 125516

UNITED THERAP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

17.5MG/5ML

0

UNITUXIN

DINUTUXIMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-03-10	PRIORITY
LABELING; Labeling	SUPPL	11	AP	2017-03-01	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-09-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	11	Null	7
SUPPL	25	Null	15

CDER Filings

UNITED THERAP

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            [companyName] => UNITED THERAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"UNITUXIN","activeIngredients":"DINUTUXIMAB","strength":"17.5MG\/5ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/29\/2020","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125516s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2020","submission":"SUPPL-25","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125516s025lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125516s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125516s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/10\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125516s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125516Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125516Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125516Orig1s000SumR.pdf\"}]","notes":">"}]
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            [actionDate] => 2020-09-29
        )

)