NDA 022387

UNITED THERAP

FDA Drug Application

Application #022387

Documents

• Letter: 2009-08-06
• Letter: 2014-05-22
• Letter: 2016-06-08
• Label: 2016-06-13
• Review: 2010-04-06
• Letter: 2011-02-14
• Letter: 2013-05-02
• Label: 2009-07-30
• Label: 2011-02-09
• Label: 2013-05-01
• Label: 2014-05-28
• Other: 2009-08-05
• Letter: 2017-10-23
• Label: 2017-10-24
• Label: 2021-04-01
• Letter: 2021-04-01
• Review: 2021-12-07
• Letter: 2022-05-23
• Label: 2022-05-23

Application Sponsors

NDA 022387

UNITED THERAP

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

0.6MG/ML

1

TYVASO

TREPROSTINIL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2009-07-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2011-02-08	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-01-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2013-04-30	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2014-05-20	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2015-06-23	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-06-06	STANDARD
EFFICACY; Efficacy	SUPPL	15	AP	2017-10-19	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2021-03-31	STANDARD
LABELING; Labeling	SUPPL	20	AP	2022-05-20	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	6
SUPPL	7	Null	0
SUPPL	8	Null	15
SUPPL	9	Null	6
SUPPL	11	Null	31
SUPPL	12	Null	0
SUPPL	14	Orphan	5
SUPPL	15	Null	7
SUPPL	17	Null	7
SUPPL	20	Null	15

CDER Filings

UNITED THERAP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22387
            [companyName] => UNITED THERAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"TYVASO","activeIngredients":"TREPROSTINIL","strength":"0.6MG\/ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/20\/2022","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022387s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2021","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022387s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2017","submission":"SUPPL-15","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022387s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022387s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2014","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022387s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022387s008lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022387s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022387LBL.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TYVASO","submission":"TREPROSTINIL","actionType":"0.6MG\/ML","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-05-20
        )

)