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002	ZONEGRAN	ZONISAMIDE	CAPSULE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N020789-002	ZONEGRAN	ZONISAMIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22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N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`84e616aacf4f…`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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	Advanced Rx of Tennessee, LLC	0bc550a7-09a7-75e4-e063-6294a90a9fc1	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
zonisamide	ZONISAMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	226d917a-33de-48cc-baf6-bd6a20668341	2024-10-23	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Zydus Lifesciences Limited	4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f	2024-08-16		Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	American Health Packaging	7cdd96c4-3263-4c28-86c0-3c24bcef16c1	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Advanced Rx Pharmacy of Tennessee, LLC	19b059f0-a08a-f75a-e063-6294a90a57db	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Viona Pharmaceuticals Inc	5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e	2023-11-10	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
zonisamide	ZONISAMIDE	Bryant Ranch Prepack	64bd9d6f-8cc0-4151-a78d-9f1437b36875	2023-10-24	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	2d569c8a-844b-44a8-81df-3f9c9300a79c	2023-04-06	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Proficient Rx LP	b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1	2022-12-01	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Unichem Pharmaceuticals (USA), Inc.	3c53d5e4-f47f-46fd-aa1c-158fd49ba9c0	2022-11-30	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Proficient Rx LP	85321a9a-08d9-49e4-8c79-86ecfc536613	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Proficient Rx LP	812582ce-fc7e-44b1-a428-7faa3701c1b8	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Exelan Pharmaceuticals, Inc.	24284954-0c29-458f-a9f8-97a7ad418ca7	2021-07-06	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