NDA 214275

ACTELION

FDA Drug Application

Application #214275

Documents

• Letter: 2021-08-02
• Label: 2021-08-02
• Review: 2021-10-27

Application Sponsors

NDA 214275

ACTELION

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008
• Prescription: 009

Application Products

001	TABLET;ORAL	200MCG	0	UPTRAVI	SELEXIPAG
002	TABLET;ORAL	400MCG	0	UPTRAVI	SELEXIPAG
003	TABLET;ORAL	600MCG	0	UPTRAVI	SELEXIPAG
004	TABLET;ORAL	800MCG	0	UPTRAVI	SELEXIPAG
005	TABLET;ORAL	1000MCG	0	UPTRAVI	SELEXIPAG
006	TABLET;ORAL	1200MCG	0	UPTRAVI	SELEXIPAG
007	TABLET;ORAL	1400MCG	0	UPTRAVI	SELEXIPAG
008	TABLET;ORAL	1600MCG	0	UPTRAVI	SELEXIPAG
009	INJECTABLE;INJECTION	1800MCG	0	UPTRAVI	SELEXIPAG

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2021-07-29

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

ACTELION

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214275
            [companyName] => ACTELION
            [docInserts] => ["",""]
            [products] => [{"drugName":"UPTRAVI","activeIngredients":"SELEXIPAG","strength":"200MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"UPTRAVI","activeIngredients":"SELEXIPAG","strength":"400MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"UPTRAVI","activeIngredients":"SELEXIPAG","strength":"600MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"UPTRAVI","activeIngredients":"SELEXIPAG","strength":"800MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"UPTRAVI","activeIngredients":"SELEXIPAG","strength":"1000MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"UPTRAVI","activeIngredients":"SELEXIPAG","strength":"1200MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"UPTRAVI","activeIngredients":"SELEXIPAG","strength":"1400MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"UPTRAVI","activeIngredients":"SELEXIPAG","strength":"1600MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"UPTRAVI","activeIngredients":"SELEXIPAG","strength":"1800MCG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/29\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214275s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/29\/2021","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\\\/2021\\\/214275s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214275Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-07-29
        )

)