Application 216834

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZILBRYSQ	ZILUCOPLAN SODIUM	SOLUTION;SUBCUTANEOUS	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	Yes	Yes
002	ZILBRYSQ	ZILUCOPLAN SODIUM	SOLUTION;SUBCUTANEOUS	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	Yes	Yes
003	ZILBRYSQ	ZILUCOPLAN SODIUM	SOLUTION;SUBCUTANEOUS	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N216834-001	ZILBRYSQ	ZILUCOPLAN SODIUM	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17
N216834-002	ZILBRYSQ	ZILUCOPLAN SODIUM	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17
N216834-003	ZILBRYSQ	ZILUCOPLAN SODIUM	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17

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
N216834-001	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13
N216834-001	10208089	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-001	10435438	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-001	10562934	2035-06-12		Drug substance	2023-11-13
N216834-001	10835574	2035-06-12		Drug product	2023-11-13
N216834-001	11014965	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-001	11535650	2035-06-12		Drug product	2023-11-13
N216834-001	11752190	2035-06-12	U-3735	Drug product	2023-11-13
N216834-001	11965040	2035-06-12		Drug product	2024-05-17
N216834-002	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13
N216834-002	10208089	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-002	10435438	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-002	10562934	2035-06-12		Drug substance	2023-11-13
N216834-002	10835574	2035-06-12		Drug product	2023-11-13
N216834-002	11014965	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-002	11535650	2035-06-12		Drug product	2023-11-13
N216834-002	11752190	2035-06-12	U-3735	Drug product	2023-11-13
N216834-002	11965040	2035-06-12		Drug product	2024-05-17
N216834-003	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13
N216834-003	10208089	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-003	10435438	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-003	10562934	2035-06-12		Drug substance	2023-11-13
N216834-003	10835574	2035-06-12		Drug product	2023-11-13
N216834-003	11014965	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-003	11535650	2035-06-12		Drug product	2023-11-13
N216834-003	11752190	2035-06-12	U-3735	Drug product	2023-11-13
N216834-003	11965040	2035-06-12		Drug product	2024-05-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216834-001	NCE	2028-10-17
N216834-001	ODE-446	2030-10-17
N216834-002	NCE	2028-10-17
N216834-002	ODE-446	2030-10-17
N216834-003	NCE	2028-10-17
N216834-003	ODE-446	2030-10-17

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 2 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 555 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N216834-001	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	10562934	2035-06-12		Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	10835574	2035-06-12		Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	11535650	2035-06-12		Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	11965040	2035-06-12		Drug product	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	10562934	2035-06-12		Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	10835574	2035-06-12		Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	11535650	2035-06-12		Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	11965040	2035-06-12		Drug product	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	10562934	2035-06-12		Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	10835574	2035-06-12		Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	11535650	2035-06-12		Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	11965040	2035-06-12		Drug product	2024-05-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216834-001	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	10562934	2035-06-12		Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	10835574	2035-06-12		Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	11535650	2035-06-12		Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	11965040	2035-06-12		Drug product	2024-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	10562934	2035-06-12		Drug substance	2023-11-13	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N216834-001	NCE	2028-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	ODE-446	2030-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	NCE	2028-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	ODE-446	2030-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	NCE	2028-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	ODE-446	2030-10-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216834-001	NCE	2028-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	ODE-446	2030-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	NCE	2028-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	ODE-446	2030-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	NCE	2028-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	ODE-446	2030-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216834-001	NCE	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	ODE-446	2030-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	NCE	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	ODE-446	2030-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-003	NCE	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-003	ODE-446	2030-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216834-001	NCE	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-001	ODE-446	2030-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-002	NCE	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-002	ODE-446	2030-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-003	NCE	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-003	ODE-446	2030-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-001	NCE	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-001	ODE-446	2030-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-002	NCE	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-002	ODE-446	2030-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-003	NCE	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-003	ODE-446	2030-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216834-001	NCE	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-001	ODE-446	2030-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-002	NCE	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-002	ODE-446	2030-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-003	NCE	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-003	ODE-446	2030-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-001	NCE	2028-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-001	ODE-446	2030-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-002	NCE	2028-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-002	ODE-446	2030-10-17	`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
ZILBRYSQ	ZILUCOPLAN	UCB, Inc.	9f1d53d6-e495-4a3a-8bb9-680a15d25034	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216834 application number: NDA216834

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84843	SUPPL	2026-01-27
84842	SUPPL	2026-01-27
84827	SUPPL	2026-01-23
81426	SUPPL	2025-03-04
81425	SUPPL	2025-03-04
81395	SUPPL	2025-03-03
81394	SUPPL	2025-03-03
78298	SUPPL	2024-04-29
78291	SUPPL	2024-04-29
77232	SUPPL	2024-01-17
76558	ORIG	2023-11-13
75836	ORIG	2023-10-18
75825	ORIG	2023-10-17