Application 219164

Type: NDA
Sponsor: ASCENDIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	YUVIWEL	NAVEPEGRITIDE	POWDER;SUBCUTANEOUS	1.3MG/VIAL	Yes	Yes
002	YUVIWEL	NAVEPEGRITIDE	POWDER;SUBCUTANEOUS	2.8MG/VIAL	Yes	Yes
003	YUVIWEL	NAVEPEGRITIDE	POWDER;SUBCUTANEOUS	5.5MG/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N219164-001	YUVIWEL	NAVEPEGRITIDE	1.3MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-02-27
N219164-002	YUVIWEL	NAVEPEGRITIDE	2.8MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-02-27
N219164-003	YUVIWEL	NAVEPEGRITIDE	5.5MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-02-27

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219164-001	8906847	2031-04-30	U-4425	Drug substance, Drug product	2026-03-16
N219164-001	10835578	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16
N219164-001	11154593	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16
N219164-001	11224661	2037-01-05		Drug substance, Drug product	2026-03-16
N219164-001	11311604	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16
N219164-001	11389510	2037-01-05		Drug substance, Drug product	2026-03-16
N219164-001	11389511	2037-01-05	U-4425	Drug product	2026-03-16
N219164-001	11413351	2037-01-05		Drug substance, Drug product	2026-03-16
N219164-001	12083182	2037-01-05	U-4425		2026-03-16
N219164-001	12156917	2037-01-05	U-4425		2026-03-16
N219164-001	12239689	2037-01-05	U-4425		2026-03-16
N219164-001	12377133	2042-11-12	U-4425	Drug product	2026-03-16
N219164-002	8906847	2031-04-30	U-4425	Drug substance, Drug product	2026-03-16
N219164-002	10835578	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16
N219164-002	11154593	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16
N219164-002	11224661	2037-01-05		Drug substance, Drug product	2026-03-16
N219164-002	11311604	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16
N219164-002	11389510	2037-01-05		Drug substance, Drug product	2026-03-16
N219164-002	11389511	2037-01-05	U-4425	Drug product	2026-03-16
N219164-002	11413351	2037-01-05		Drug substance, Drug product	2026-03-16
N219164-002	12083182	2037-01-05	U-4425		2026-03-16
N219164-002	12156917	2037-01-05	U-4425		2026-03-16
N219164-002	12239689	2037-01-05	U-4425		2026-03-16
N219164-002	12377133	2042-11-12	U-4425	Drug product	2026-03-16
N219164-003	8906847	2031-04-30	U-4425	Drug substance, Drug product	2026-03-16
N219164-003	10835578	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16
N219164-003	11154593	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16
N219164-003	11224661	2037-01-05		Drug substance, Drug product	2026-03-16
N219164-003	11311604	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16
N219164-003	11389510	2037-01-05		Drug substance, Drug product	2026-03-16
N219164-003	11389511	2037-01-05	U-4425	Drug product	2026-03-16
N219164-003	11413351	2037-01-05		Drug substance, Drug product	2026-03-16
N219164-003	12083182	2037-01-05	U-4425		2026-03-16
N219164-003	12156917	2037-01-05	U-4425		2026-03-16
N219164-003	12239689	2037-01-05	U-4425		2026-03-16
N219164-003	12377133	2042-11-12	U-4425	Drug product	2026-03-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219164-001	NCE	2031-02-27
N219164-001	ODE-516	2033-02-27
N219164-002	NCE	2031-02-27
N219164-002	ODE-516	2033-02-27
N219164-003	NCE	2031-02-27
N219164-003	ODE-516	2033-02-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219164-001	YUVIWEL	1.3MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	YUVIWEL	2.8MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	YUVIWEL	5.5MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-02-27	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-001	YUVIWEL	1.3MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-002	YUVIWEL	2.8MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-003	YUVIWEL	5.5MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-02-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219164-001	8906847	2031-04-30	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	10835578	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	11154593	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	11224661	2037-01-05		Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	11311604	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	11389510	2037-01-05		Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	11389511	2037-01-05	U-4425	Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	11413351	2037-01-05		Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	12083182	2037-01-05	U-4425		2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	12156917	2037-01-05	U-4425		2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	12239689	2037-01-05	U-4425		2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	12377133	2042-11-12	U-4425	Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	8906847	2031-04-30	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	10835578	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	11154593	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	11224661	2037-01-05		Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	11311604	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	11389510	2037-01-05		Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	11389511	2037-01-05	U-4425	Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	11413351	2037-01-05		Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	12083182	2037-01-05	U-4425		2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	12156917	2037-01-05	U-4425		2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	12239689	2037-01-05	U-4425		2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	12377133	2042-11-12	U-4425	Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	8906847	2031-04-30	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	10835578	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	11154593	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	11224661	2037-01-05		Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	11311604	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	11389510	2037-01-05		Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	11389511	2037-01-05	U-4425	Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	11413351	2037-01-05		Drug substance, Drug product	2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	12083182	2037-01-05	U-4425		2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	12156917	2037-01-05	U-4425		2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	12239689	2037-01-05	U-4425		2026-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	12377133	2042-11-12	U-4425	Drug product	2026-03-16	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-001	8906847	2031-04-30	U-4425	Drug substance, Drug product	2026-03-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-001	10835578	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-001	11154593	2037-01-05	U-4425	Drug substance, Drug product	2026-03-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-001	11224661	2037-01-05		Drug substance, Drug product	2026-03-16	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N219164-001	NCE	2031-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-001	ODE-516	2033-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	NCE	2031-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-002	ODE-516	2033-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	NCE	2031-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219164-003	ODE-516	2033-02-27	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-001	NCE	2031-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-001	ODE-516	2033-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-002	NCE	2031-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-002	ODE-516	2033-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-003	NCE	2031-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219164-003	ODE-516	2033-02-27	`a50c72e98297…`

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
Yuviwel	NAVEPEGRITIDE	Ascendis Pharma Endocrinology, Inc.	e01c1197-338f-414c-b804-808e129ebc8c	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219164 application number: NDA219164

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85921	ORIG	2026-03-30
85266	ORIG	2026-03-04
85219	ORIG	2026-03-03