UNITED THERAP FDA Approval NDA 021272

NDA 021272

UNITED THERAP

FDA Drug Application

Application #021272

Documents

Letter2008-02-07
Letter2010-01-15
Letter2013-10-01
Label2002-05-21
Label2006-03-22
Label2008-09-19
Label2008-02-14
Label2013-09-27
Review2002-07-31
Review2011-10-10
Review2015-11-18
Letter2002-05-21
Letter2006-01-30
Letter2006-03-23
Letter2008-09-16
Letter2011-02-14
Letter2014-12-30
Letter2013-09-26
Label2010-01-12
Label2011-02-09
Label2013-09-27
Review2014-01-16
Label2016-09-27
Label2018-06-12
Letter2018-06-14
Label2018-07-31
Letter2018-08-03
Letter2021-02-17
Label2021-03-23
Letter2021-09-13
Label2021-09-13

Application Sponsors

NDA 021272UNITED THERAP

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001INJECTABLE;IV (INFUSION), SUBCUTANEOUS1MG/ML1REMODULINTREPROSTINIL
002INJECTABLE;IV (INFUSION), SUBCUTANEOUS2.5MG/ML1REMODULINTREPROSTINIL
003INJECTABLE;IV (INFUSION), SUBCUTANEOUS5MG/ML1REMODULINTREPROSTINIL
004INJECTABLE;IV (INFUSION), SUBCUTANEOUS10MG/ML1REMODULINTREPROSTINIL
005INJECTABLE;IV (INFUSION), SUBCUTANEOUS20MG/ML1REMODULINTREPROSTINIL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2002-05-21PRIORITY
EFFICACY; EfficacySUPPL2AP2004-11-24STANDARD
LABELING; LabelingSUPPL3AP2006-01-20STANDARD
EFFICACY; EfficacySUPPL5AP2006-03-20PRIORITY
LABELING; LabelingSUPPL8AP2008-09-12STANDARD
LABELING; LabelingSUPPL9AP2008-02-04STANDARD
LABELING; LabelingSUPPL11AP2010-01-08STANDARD
LABELING; LabelingSUPPL15AP2011-02-08UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2014-12-22N/A
LABELING; LabelingSUPPL20AP2013-09-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2014-01-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2016-01-22PRIORITY
LABELING; LabelingSUPPL25AP2018-07-30STANDARD
LABELING; LabelingSUPPL26AP2018-06-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL30TA2020-08-19N/A
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2021-07-30N/A

Submissions Property Types

ORIG1Null25
SUPPL2Null41
SUPPL11Null6
SUPPL15Null6
SUPPL19Null6
SUPPL20Null6
SUPPL21Null14
SUPPL22Null14
SUPPL25Null7
SUPPL26Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP

CDER Filings

UNITED THERAP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21272
            [companyName] => UNITED THERAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"REMODULIN","activeIngredients":"TREPROSTINIL","strength":"1MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"REMODULIN","activeIngredients":"TREPROSTINIL","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"REMODULIN","activeIngredients":"TREPROSTINIL","strength":"5MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"REMODULIN","activeIngredients":"TREPROSTINIL","strength":"10MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"REMODULIN","activeIngredients":"TREPROSTINIL","strength":"20MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/30\/2021","submission":"SUPPL-32","supplementCategories":"Manufacturing (CMC)-New Strength","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021272Orig1s032lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2021","submission":"SUPPL-32","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021272Orig1s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2020","submission":"SUPPL-30","supplementCategories":"Tentative Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021272Orig1s030lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2018","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208276s000,021272s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021272s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021272s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021272s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2013","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021272s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2013","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021272s020lbledt.pdf\"}]","notes":""},{"actionDate":"02\/08\/2011","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021272s015lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2010","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021272s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2008","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021272s008lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2008","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021272s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2006","submission":"SUPPL-5","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021272S005lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21272lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"REMODULIN","submission":"TREPROSTINIL","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REMODULIN","submission":"TREPROSTINIL","actionType":"2.5MG\/ML","submissionClassification":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REMODULIN","submission":"TREPROSTINIL","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REMODULIN","submission":"TREPROSTINIL","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REMODULIN","submission":"TREPROSTINIL","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-07-30
        )

)
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