Application 214273

Type: NDA
Sponsor: AZURITY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZONISADE	ZONISAMIDE	SUSPENSION;ORAL	100MG/5ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214273-001	ZONISADE	ZONISAMIDE	100MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-07-15

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214273-001	11478456	2038-08-18	U-3458		2022-10-26
N214273-001	11529333	2038-08-18		Drug product	2022-12-27
N214273-001	12491179	2038-08-18		Drug product	2025-12-12

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
2026-02-19 14:30 UTC	2026-02	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 51 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	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214273-001	12491179	2038-08-18		Drug product	2025-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`a67488948f0b…`

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
ZONISADE	ZONISAMIDE	Azurity Pharmaceuticals, Inc.	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214273 application number: NDA214273 ndc (product): 52652-8001

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52652-8001	ZONISADE	ZONISAMIDE	Azurity Phramaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74059	ORIG	2023-04-25
71580	ORIG	2022-07-19
71577	ORIG	2022-07-18
71576	ORIG	2022-07-18