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 45.

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 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 582 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-11-14 07:37:17	2026-10	N216834-001	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	10562934	2035-06-12		Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	10835574	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	11535650	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	11965040	2035-06-12		Drug product	2024-05-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10562934	2035-06-12		Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10835574	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	11535650	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	11965040	2035-06-12		Drug product	2024-05-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10562934	2035-06-12		Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10835574	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	11535650	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	11965040	2035-06-12		Drug product	2024-05-17	`d4dbc9d85df4…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-11-14 07:37:17	2026-10	N216834-001	NCE	2028-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	ODE-446	2030-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	NCE	2028-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	ODE-446	2030-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	NCE	2028-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	ODE-446	2030-10-17	`d4dbc9d85df4…`
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…`

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