Application 216490

Type: NDA
Sponsor: ASCENDIS PHARMA BONE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	YORVIPATH	PALOPEGTERIPARATIDE	SOLUTION;SUBCUTANEOUS	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	Yes	Yes
002	YORVIPATH	PALOPEGTERIPARATIDE	SOLUTION;SUBCUTANEOUS	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	Yes	No
003	YORVIPATH	PALOPEGTERIPARATIDE	SOLUTION;SUBCUTANEOUS	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	Yes	No

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
N216490-001	YORVIPATH	PALOPEGTERIPARATIDE	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09
N216490-002	YORVIPATH	PALOPEGTERIPARATIDE	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09
N216490-003	YORVIPATH	PALOPEGTERIPARATIDE	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09

Orange Book patents#

Current patent rows page 1 of 1 · 27 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216490-001	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05
N216490-001	11590207	2037-09-28	U-3982		2024-09-05
N216490-001	11759504	2037-09-28		Drug product	2024-09-05
N216490-001	11857603	2037-09-28	U-3982		2024-09-05
N216490-001	11890326	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-001	11918628	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-001	12295989	2037-09-28	U-3982		2025-05-29
N216490-001	12453778	2037-09-28	U-3982		2025-11-12
N216490-001	12403182	2042-11-12	U-3982	Drug product	2025-09-05
N216490-002	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05
N216490-002	11590207	2037-09-28	U-3982		2024-09-05
N216490-002	11759504	2037-09-28		Drug product	2024-09-05
N216490-002	11857603	2037-09-28	U-3982		2024-09-05
N216490-002	11890326	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-002	11918628	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-002	12295989	2037-09-28	U-3982		2025-05-29
N216490-002	12453778	2037-09-28	U-3982		2025-11-12
N216490-002	12403182	2042-11-12	U-3982	Drug product	2025-09-05
N216490-003	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05
N216490-003	11590207	2037-09-28	U-3982		2024-09-05
N216490-003	11759504	2037-09-28		Drug product	2024-09-05
N216490-003	11857603	2037-09-28	U-3982		2024-09-05
N216490-003	11890326	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-003	11918628	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-003	12295989	2037-09-28	U-3982		2025-05-29
N216490-003	12453778	2037-09-28	U-3982		2025-11-12
N216490-003	12403182	2042-11-12	U-3982	Drug product	2025-09-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216490-001	NCE	2029-08-09
N216490-001	ODE-492	2031-08-09
N216490-002	NCE	2029-08-09
N216490-002	ODE-492	2031-08-09
N216490-003	NCE	2029-08-09
N216490-003	ODE-492	2031-08-09

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	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 237 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	N216490-001	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11590207	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11759504	2037-09-28		Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11857603	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11890326	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11918628	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	12295989	2037-09-28	U-3982		2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	12453778	2037-09-28	U-3982		2025-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	12403182	2042-11-12	U-3982	Drug product	2025-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11590207	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11759504	2037-09-28		Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11857603	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11890326	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11918628	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	12295989	2037-09-28	U-3982		2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	12453778	2037-09-28	U-3982		2025-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	12403182	2042-11-12	U-3982	Drug product	2025-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11590207	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11759504	2037-09-28		Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11857603	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11890326	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11918628	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	12295989	2037-09-28	U-3982		2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	12453778	2037-09-28	U-3982		2025-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	12403182	2042-11-12	U-3982	Drug product	2025-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216490-001	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11590207	2037-09-28	U-3982		2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11759504	2037-09-28		Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11857603	2037-09-28	U-3982		2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11890326	2037-09-28		Drug substance, Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11918628	2037-09-28		Drug substance, Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	12295989	2037-09-28	U-3982		2025-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	12453778	2037-09-28	U-3982		2025-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	12403182	2042-11-12	U-3982	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	11590207	2037-09-28	U-3982		2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	11759504	2037-09-28		Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	11857603	2037-09-28	U-3982		2024-09-05	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N216490-001	NCE	2029-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	ODE-492	2031-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	NCE	2029-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	ODE-492	2031-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	NCE	2029-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	ODE-492	2031-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216490-001	NCE	2029-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	ODE-492	2031-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	NCE	2029-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	ODE-492	2031-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-003	NCE	2029-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-003	ODE-492	2031-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-001	NCE	2029-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-001	ODE-492	2031-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-002	NCE	2029-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-002	ODE-492	2031-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-003	NCE	2029-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-003	ODE-492	2031-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216490-001	NCE	2029-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-001	ODE-492	2031-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-002	NCE	2029-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-002	ODE-492	2031-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-003	NCE	2029-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-003	ODE-492	2031-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-001	NCE	2029-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-001	ODE-492	2031-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-002	NCE	2029-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-002	ODE-492	2031-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-003	NCE	2029-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-003	ODE-492	2031-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-001	NCE	2029-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-001	ODE-492	2031-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-002	NCE	2029-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-002	ODE-492	2031-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-003	NCE	2029-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-003	ODE-492	2031-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-001	NP	2027-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-001	ODE-492	2031-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-002	NP	2027-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-002	ODE-492	2031-08-09	`03ed91905a0d…`

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
Yorvipath	PALOPEGTERIPARATIDE	Ascendis Pharma, Endocrinology, Inc.	a1fa23fd-c434-443e-9a17-5750578c8602	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216490 application number: NDA216490

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83846	SUPPL	2025-10-21
83804	SUPPL	2025-10-20
83803	SUPPL	2025-10-20
79565	ORIG	2024-10-15
79375	ORIG	2024-08-12
79370	ORIG	2024-08-12