Application 761177

Type: BLA
Sponsor: ACENDIS PHARMA ENDOCRINOLOGY DIV A/S

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SKYTROFA	LONAPEGSOMATROPIN-TCGD	INJECTABLE;INJECTION	3MG	No	No
002	SKYTROFA	LONAPEGSOMATROPIN-TCGD	INJECTABLE;INJECTION	3.6MG	No	No
003	SKYTROFA	LONAPEGSOMATROPIN-TCGD	INJECTABLE;INJECTION	4.3MG	No	No
004	SKYTROFA	LONAPEGSOMATROPIN-TCGD	INJECTABLE;INJECTION	5.2MG	No	No
005	SKYTROFA	LONAPEGSOMATROPIN-TCGD	INJECTABLE;INJECTION	6.3MG	No	No
006	SKYTROFA	LONAPEGSOMATROPIN-TCGD	INJECTABLE;INJECTION	7.6MG	No	No
007	SKYTROFA	LONAPEGSOMATROPIN-TCGD	INJECTABLE;INJECTION	9.1MG	No	No
008	SKYTROFA	LONAPEGSOMATROPIN-TCGD	INJECTABLE;INJECTION	11MG	No	No
009	SKYTROFA	LONAPEGSOMATROPIN-TCGD	INJECTABLE;INJECTION	13.3MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
73362-003	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-003	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-003	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-003	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-003	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma, Inc.	BLA	Current
73362-004	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-004	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-004	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-004	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma, Inc.	BLA	Current
73362-004	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-005	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma, Inc.	BLA	Current
73362-005	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-005	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-005	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-005	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-006	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-006	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-006	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-006	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma, Inc.	BLA	Current
73362-006	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-007	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-007	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma, Inc.	BLA	Current
73362-007	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-007	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-007	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-008	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-008	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-008	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-008	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma, Inc.	BLA	Current
73362-008	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-009	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-009	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma, Inc.	BLA	Current
73362-009	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-009	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-009	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-010	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-010	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-010	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-010	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma, Inc.	BLA	Current
73362-010	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-011	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-011	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-011	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current
73362-011	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma, Inc.	BLA	Current
73362-011	Skytrofa	Lonapegsomatropin-tcgd	Ascendis Pharma Endocrinology, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82965	SUPPL	2025-07-28
82955	SUPPL	2025-07-28
82796	SUPPL	2025-07-11
82779	SUPPL	2025-07-11
72457	SUPPL	2022-10-24
72438	SUPPL	2022-10-21
68746	ORIG	2021-09-24
68474	ORIG	2021-08-27
68466	ORIG	2021-08-25

Application 761177

Related Records#

Application Products#

NDC Listings For This Application#

Documents#