NDA 214324

UNITED THERAP

FDA Drug Application

Application #214324

Documents

• Label: 2022-05-24
• Letter: 2022-05-24
• Review: 2022-07-06

Application Sponsors

NDA 214324

UNITED THERAP

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	POWDER;INHALATION	16MCG	2	TYVASO DPI	TREPROSTINIL
002	POWDER;INHALATION	0.032MG/INH	1	TYVASO DPI	TREPROSTINIL
003	POWDER;INHALATION	0.048MG/INH	1	TYVASO DPI	TREPROSTINIL
004	POWDER;INHALATION	0.064MG/INH	1	TYVASO DPI	TREPROSTINIL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-05-23

PRIORITY

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

TBD

CDER Filings

UNITED THERAP

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            [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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