Application 214938

Type: NDA
Sponsor: BIOMARIN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VOXZOGO	VOSORITIDE	INJECTABLE;INJECTION	0.4MG	No	No
002	VOXZOGO	VOSORITIDE	INJECTABLE;INJECTION	0.56MG	No	No
003	VOXZOGO	VOSORITIDE	INJECTABLE;INJECTION	1.2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N214938-001	VOXZOGO	VOSORITIDE	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19
N214938-002	VOXZOGO	VOSORITIDE	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19
N214938-003	VOXZOGO	VOSORITIDE	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214938-001	RE48267	2030-05-20	U-3927		2021-12-17
N214938-001	8198242	2035-06-11	U-3927	Drug substance, Drug product	2021-12-17
N214938-001	10646550	2036-08-01	U-3927	Drug product	2021-12-17
N214938-001	11590204	2036-08-01	U-3927	Drug product	2024-05-20
N214938-001	11911446	2036-08-01	U-3927		2024-05-20
N214938-001	12514906	2036-08-01	U-3927	Drug product	2026-02-03
N214938-001	9907834	2036-08-01		Drug product	2021-12-17
N214938-001	12233106	2042-07-11	U-3927		2025-03-21
N214938-002	RE48267	2030-05-20	U-3927		2021-12-17
N214938-002	8198242	2035-06-11	U-3927	Drug substance, Drug product	2021-12-17
N214938-002	10646550	2036-08-01	U-3927	Drug product	2021-12-17
N214938-002	11590204	2036-08-01	U-3927	Drug product	2024-05-20
N214938-002	11911446	2036-08-01	U-3927		2024-05-20
N214938-002	12514906	2036-08-01	U-3927	Drug product	2026-02-03
N214938-002	9907834	2036-08-01		Drug product	2021-12-17
N214938-002	12233106	2042-07-11	U-3927		2025-03-21
N214938-003	RE48267	2030-05-20	U-3927		2021-12-17
N214938-003	8198242	2035-06-11	U-3927	Drug substance, Drug product	2021-12-17
N214938-003	10646550	2036-08-01	U-3927	Drug product	2021-12-17
N214938-003	11590204	2036-08-01	U-3927	Drug product	2024-05-20
N214938-003	11911446	2036-08-01	U-3927		2024-05-20
N214938-003	12514906	2036-08-01	U-3927	Drug product	2026-02-03
N214938-003	9907834	2036-08-01		Drug product	2021-12-17
N214938-003	12233106	2042-07-11	U-3927		2025-03-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214938-001	NPP	2026-10-20
N214938-001	NCE	2026-11-19
N214938-001	ODE-387	2028-11-19
N214938-001	ODE-449	2030-10-20
N214938-002	NPP	2026-10-20
N214938-002	NCE	2026-11-19
N214938-002	ODE-387	2028-11-19
N214938-002	ODE-449	2030-10-20
N214938-003	NPP	2026-10-20
N214938-003	NCE	2026-11-19
N214938-003	ODE-387	2028-11-19
N214938-003	ODE-449	2030-10-20

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.

Product history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214938-002	VOXZOGO	0.56MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214938-003	VOXZOGO	1.2MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214938-001	VOXZOGO	0.4MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2021-11-19	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 486 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214938-001	RE48267	2030-05-20	U-3927		2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	8198242	2030-06-11	U-3927	Drug substance, Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	10646550	2036-08-01	U-3927	Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	11590204	2036-08-01	U-3927	Drug product	2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	11911446	2036-08-01	U-3927		2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	12514906	2036-08-01	U-3927	Drug product	2026-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	9907834	2036-08-01		Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	12233106	2042-07-11	U-3927		2025-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	RE48267	2030-05-20	U-3927		2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	8198242	2030-06-11	U-3927	Drug substance, Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	10646550	2036-08-01	U-3927	Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	11590204	2036-08-01	U-3927	Drug product	2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	11911446	2036-08-01	U-3927		2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	12514906	2036-08-01	U-3927	Drug product	2026-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	9907834	2036-08-01		Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	12233106	2042-07-11	U-3927		2025-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	RE48267	2030-05-20	U-3927		2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	8198242	2030-06-11	U-3927	Drug substance, Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	10646550	2036-08-01	U-3927	Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	11590204	2036-08-01	U-3927	Drug product	2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	11911446	2036-08-01	U-3927		2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	12514906	2036-08-01	U-3927	Drug product	2026-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	9907834	2036-08-01		Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	12233106	2042-07-11	U-3927		2025-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	RE48267	2030-05-20	U-3927		2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	8198242	2030-06-11	U-3927	Drug substance, Drug product	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	10646550	2036-08-01	U-3927	Drug product	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	11590204	2036-08-01	U-3927	Drug product	2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	11911446	2036-08-01	U-3927		2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	9907834	2036-08-01		Drug product	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	12233106	2042-07-11	U-3927		2025-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	RE48267	2030-05-20	U-3927		2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	8198242	2030-06-11	U-3927	Drug substance, Drug product	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	10646550	2036-08-01	U-3927	Drug product	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	11590204	2036-08-01	U-3927	Drug product	2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	11911446	2036-08-01	U-3927		2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	9907834	2036-08-01		Drug product	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	12233106	2042-07-11	U-3927		2025-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-003	RE48267	2030-05-20	U-3927		2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-003	8198242	2030-06-11	U-3927	Drug substance, Drug product	2021-12-17	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 273 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214938-001	NPP	2026-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	NCE	2026-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	ODE-387	2028-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-001	ODE-449	2030-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	NPP	2026-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	NCE	2026-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	ODE-387	2028-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-002	ODE-449	2030-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	NPP	2026-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	NCE	2026-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	ODE-387	2028-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214938-003	ODE-449	2030-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	NPP	2026-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	NCE	2026-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	ODE-387	2028-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-001	ODE-449	2030-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	NPP	2026-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	NCE	2026-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	ODE-387	2028-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-002	ODE-449	2030-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-003	NPP	2026-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-003	NCE	2026-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-003	ODE-387	2028-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214938-003	ODE-449	2030-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214938-001	NPP	2026-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-001	NCE	2026-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-001	ODE-387	2028-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-001	ODE-449	2030-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-002	NPP	2026-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-002	NCE	2026-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-002	ODE-387	2028-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-002	ODE-449	2030-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-003	NPP	2026-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-003	NCE	2026-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-003	ODE-387	2028-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214938-003	ODE-449	2030-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214938-001	NPP	2026-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214938-001	NCE	2026-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214938-001	ODE-387	2028-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214938-001	ODE-449	2030-10-20	`fd3edfee7708…`

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
VOXZOGO 0.4mg	VOSORITIDE	BioMarin Pharmaceutical Inc.	228e8560-04a4-4bb1-a81f-29531a9e4d27	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214938 application number: NDA214938 ndc (product): 68135-181 ndc (product): 68135-119 ndc (product): 68135-082

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68135-082	VOXZOGO 0.4mg	vosoritide	BioMarin Pharmaceutical Inc.	NDA	Current
68135-119	VOXZOGO 0.56mg	vosoritide	BioMarin Pharmaceutical Inc.	NDA	Current
68135-181	VOXZOGO 1.2mg	vosoritide	BioMarin Pharmaceutical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81918	SUPPL	2025-04-10
80175	SUPPL	2024-11-05
80147	SUPPL	2024-11-05
75892	SUPPL	2023-10-24
75887	SUPPL	2023-10-23
69747	ORIG	2021-12-22
69385	ORIG	2021-11-23
69366	ORIG	2021-11-22