ACTELION FDA Approval NDA 214275

NDA 214275

ACTELION

FDA Drug Application

Application #214275

Documents

Letter2021-08-02
Label2021-08-02

Application Sponsors

NDA 214275ACTELION

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007
Prescription008
Prescription009

Application Products

001TABLET;ORAL200MCG0UPTRAVISELEXIPAG
002TABLET;ORAL400MCG0UPTRAVISELEXIPAG
003TABLET;ORAL600MCG0UPTRAVISELEXIPAG
004TABLET;ORAL800MCG0UPTRAVISELEXIPAG
005TABLET;ORAL1000MCG0UPTRAVISELEXIPAG
006TABLET;ORAL1200MCG0UPTRAVISELEXIPAG
007TABLET;ORAL1400MCG0UPTRAVISELEXIPAG
008TABLET;ORAL1600MCG0UPTRAVISELEXIPAG
009INJECTABLE;INJECTION1800MCG0UPTRAVISELEXIPAG

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-07-29STANDARD

Submissions Property Types

ORIG1Null40

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
        )

)

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