UNITED THERAP FDA Approval NDA 203496

NDA 203496

UNITED THERAP

FDA Drug Application

Application #203496

Documents

Letter2014-10-08
Letter2016-01-28
Label2013-12-23
Review2014-12-09
Summary Review2014-12-09
Letter2013-12-24
Label2014-10-09
Label2016-02-11
Label2017-01-24
Letter2017-01-27
Label2017-06-14
Letter2017-06-16
Label2019-10-21
Letter2019-10-22
Label2021-04-12

Application Sponsors

NDA 203496UNITED THERAP

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 0.125MG BASE1ORENITRAMTREPROSTINIL DIOLAMINE
002TABLET, EXTENDED RELEASE;ORALEQ 0.25MG BASE1ORENITRAMTREPROSTINIL DIOLAMINE
003TABLET, EXTENDED RELEASE;ORALEQ 1MG BASE1ORENITRAMTREPROSTINIL DIOLAMINE
004TABLET, EXTENDED RELEASE;ORALEQ 2.5MG BASE1ORENITRAMTREPROSTINIL DIOLAMINE
005TABLET, EXTENDED RELEASE;ORALEQ 5MG BASE1ORENITRAMTREPROSTINIL DIOLAMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2013-12-20STANDARD
EFFICACY; EfficacySUPPL2AP2016-01-28STANDARD
LABELING; LabelingSUPPL6AP2017-01-24STANDARD
LABELING; LabelingSUPPL7AP2017-06-07STANDARD
EFFICACY; EfficacySUPPL11AP2019-10-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2020-11-03STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null15
SUPPL6Null6
SUPPL7Null7
SUPPL11Null7

CDER Filings

UNITED THERAP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203496
            [companyName] => UNITED THERAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORENITRAM","activeIngredients":"TREPROSTINIL DIOLAMINE","strength":"EQ 0.125MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ORENITRAM","activeIngredients":"TREPROSTINIL DIOLAMINE","strength":"EQ 0.25MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ORENITRAM","activeIngredients":"TREPROSTINIL DIOLAMINE","strength":"EQ 1MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ORENITRAM","activeIngredients":"TREPROSTINIL DIOLAMINE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ORENITRAM","activeIngredients":"TREPROSTINIL DIOLAMINE","strength":"EQ 5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/03\/2020","submission":"SUPPL-13","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203496Orig1s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2019","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203496s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203496s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203496s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2016","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203496s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203496s001lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/20\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203496Orig1s000lbl_edt.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/20\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203496Orig1s000lbl_edt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203496Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203496Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203496Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/03\/2020","submission":"SUPPL-13","supplementCategories":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203496Orig1s013lbl.pdf\"}]","notes":">"},{"actionDate":"10\/18\/2019","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203496s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203496Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"06\/07\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203496s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203496Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/24\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203496s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203496Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"01\/28\/2016","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203496s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203496Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"10\/06\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203496s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203496Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-11-03
        )

)
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