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SKYTROFA

BLA · Biologics License Application · Sponsor: ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S · Approved 2021-08-25

Drug application

FDA Application #
BLA761177
Application type
Biologics License Application
Brand name
SKYTROFA
Generic name
LONAPEGSOMATROPIN-TCGD
Active ingredients
LONAPEGSOMATROPIN-TCGD
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S
Manufacturer
Ascendis Pharma Endocrinology, Inc.
First approval
2021-08-25

Source

Authoritative
Drugs@FDA application overview
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