ACENDIS PHARMA ENDOCRINOLOGY DIV A/S FDA Approval BLA 761177

BLA 761177

ACENDIS PHARMA ENDOCRINOLOGY DIV A/S

FDA Drug Application

Application #761177

Documents

Label2021-08-25
Letter2021-08-27

Application Sponsors

BLA 761177ACENDIS PHARMA ENDOCRINOLOGY DIV A/S

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007
Prescription008
Prescription009

Application Products

001INJECTABLE;INJECTION3MG0SKYTROFALONAPEGSOMATROPIN-TCGD
002INJECTABLE;INJECTION3.6MG0SKYTROFALONAPEGSOMATROPIN-TCGD
003INJECTABLE;INJECTION4.3MG0SKYTROFALONAPEGSOMATROPIN-TCGD
004INJECTABLE;INJECTION5.2MG0SKYTROFALONAPEGSOMATROPIN-TCGD
005INJECTABLE;INJECTION6.3MG0SKYTROFALONAPEGSOMATROPIN-TCGD
006INJECTABLE;INJECTION7.6MG0SKYTROFALONAPEGSOMATROPIN-TCGD
007INJECTABLE;INJECTION9.1MG0SKYTROFALONAPEGSOMATROPIN-TCGD
008INJECTABLE;INJECTION11MG0SKYTROFALONAPEGSOMATROPIN-TCGD
009INJECTABLE;INJECTION13.3MG0SKYTROFALONAPEGSOMATROPIN-TCGD

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-08-25STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

ACENDIS PHARMA ENDOCRINOLOGY DIV A/S
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            [companyName] => ACENDIS PHARMA ENDOCRINOLOGY DIV A/S
            [docInserts] => ["",""]
            [products] => [{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"3MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"3.6MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"4.3MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"5.2MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"6.3MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"7.6MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"9.1MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"11MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"13.3MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
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            [supplements] => 
            [actionDate] => 2021-08-25
        )

)

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