Application 020789

Type: NDA
Sponsor: SUNOVION PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZONEGRAN	ZONISAMIDE	CAPSULE;ORAL	100MG	Yes	Yes
002	ZONEGRAN	ZONISAMIDE	CAPSULE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ZONEGRAN	ZONISAMIDE	CAPSULE;ORAL	25MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	RLD / RS	Approval date
N020789-001	ZONEGRAN	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27
N020789-002	ZONEGRAN	ZONISAMIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22
N020789-003	ZONEGRAN	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020789-001	AB
N020789-003	AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020789-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020789-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020789-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020789-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020789-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020789-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020789-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020789-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020789-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020789-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020789-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020789-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020789-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020789-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020789-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020789-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020789-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020789-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020789-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020789-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020789-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020789-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020789-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020789-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020789-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020789-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020789-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020789-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020789-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020789-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020789-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020789-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020789-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020789-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020789-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020789-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020789-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020789-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020789-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020789-003	AB	1	`74a2ff9319b5…`

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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	994e3ce0-f30b-47b1-aa42-b1ed37fb7c12	2026-09-08	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	40094d96-e979-4b3e-840f-a96677480f96	2026-08-18	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
zonisamide	ZONISAMIDE	Cipla USA Inc.	e8f368cb-6a07-4178-95fa-1d5a209171ed	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	467a73f0-1cd1-46bf-83b3-ee38badb761c	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Sun Pharmaceutical Industries, Inc.	3164d438-90bf-420a-9a56-5498b987f91c	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	50bb1a0a-a66d-4a13-a456-a10c1b8c8e94	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	597f0a0b-e162-497c-9871-f2b73ebad245	2026-04-06	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	BluePoint Laboratories	345efcc4-6a36-4ddf-8b6c-9c6c844dab0a	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Aurobindo Pharma Limited	ab0631ca-5339-4570-bc27-f1dd92de1d6f	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	1a859304-804a-4588-9961-c2e6ae09aadb	2025-11-26	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Glenmark Pharmaceuticals Inc., USA	fe15e56e-8b86-4a65-825c-31d37dd81612	2025-10-27	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	AvPAK	b20a51ef-255e-1eb0-c0e1-461cde46b887	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	33b84aaa-044d-4c15-bb21-d1ce8674eec9	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	5000f95c-c78d-4150-9a69-0ee2943cf2c3	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Preferred Pharmaceuticals, Inc.	53ecba6c-0de4-4e11-81d5-6deac79accd5	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
ZONISADE	ZONISAMIDE	Azurity Pharmaceuticals, Inc.	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	2025-09-08	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Preferred Pharmaceuticals Inc	061fdccc-d08e-4e42-8a32-54afb6c89701	2025-08-01	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Direct_Rx	35bcaee1-001f-82da-e063-6394a90a4a0f	2025-05-22	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Direct_Rx	e64b78d8-79de-337b-e053-2a95a90a4861	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59212-680	Zonegran	Zonisamide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-680	Zonegran	zonisamide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-680	Zonegran	Zonisamide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-680	Zonegran	Zonisamide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-681	Zonegran	Zonisamide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-681	Zonegran	zonisamide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-681	Zonegran	Zonisamide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-681	Zonegran	Zonisamide	Concordia Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62563	SUPPL	2020-04-14
62558	SUPPL	2020-04-14
62557	SUPPL	2020-04-14
3378	SUPPL	2016-04-08
35380	SUPPL	2016-04-07
35375	SUPPL	2015-07-14
3373	SUPPL	2015-06-22
44073	ORIG	2012-02-03
13448	SUPPL	2012-01-31
25851	SUPPL	2012-01-30
35379	SUPPL	2011-09-29
25853	SUPPL	2011-09-27
3377	SUPPL	2011-05-31
25852	SUPPL	2010-04-21
3376	SUPPL	2010-04-21
35377	SUPPL	2010-04-20
13449	SUPPL	2010-04-20
23192	ORIG	2009-09-30
35378	SUPPL	2009-05-13
35376	SUPPL	2009-05-13
3375	SUPPL	2009-05-04
3374	SUPPL	2009-05-04
3372	SUPPL	2006-12-04
35374	SUPPL	2006-11-22
35373	SUPPL	2003-08-28
25850	SUPPL	2003-08-28
13447	SUPPL	2002-10-07
3371	SUPPL	2002-10-07
41708	ORIG	2000-03-27
25849	ORIG	2000-03-27
13446	ORIG	2000-03-27