Application 761177

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761177	Skytrofa	lonapegsomatropin-tcgd	351(a)	Rx	2026-07-01

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Skytrofa	LONAPEGSOMATROPIN-TCGD	Ascendis Pharma Endocrinology, Inc.	9229f871-bc61-4ddc-8122-d126d40e36ac	2026-07-23	Warnings, Adverse reactions	Exact identifier application number: BLA761177 ndc (product): 73362-008 ndc (product): 73362-010 ndc (product): 73362-011 ndc (product): 73362-006 ndc (product): 73362-003 ndc (product): 73362-009 ndc (product): 73362-007 ndc (product): 73362-005 ndc (product): 73362-004

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

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, Inc.	BLA	Current
73362-003	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 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 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, 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 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
73362-008	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 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
73362-010	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