UNITED THERAP FDA Approval NDA 214324

NDA 214324

UNITED THERAP

FDA Drug Application

Application #214324

Documents

Label2022-05-24
Letter2022-05-24

Application Sponsors

NDA 214324UNITED THERAP

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001POWDER;INHALATION16MCG2TYVASO DPITREPROSTINIL
002POWDER;INHALATION0.032MG/INH1TYVASO DPITREPROSTINIL
003POWDER;INHALATION0.048MG/INH1TYVASO DPITREPROSTINIL
004POWDER;INHALATION0.064MG/INH1TYVASO DPITREPROSTINIL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-05-23PRIORITY

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionTBD

CDER Filings

UNITED THERAP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214324
            [companyName] => UNITED THERAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"TYVASO DPI","activeIngredients":"TREPROSTINIL","strength":"16MCG","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/23\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214324s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214324s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214324Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-05-23
        )

)

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