Application 077636

Type: ANDA
Sponsor: CELLTRION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZONISAMIDE	ZONISAMIDE	CAPSULE;ORAL	100MG	No	No
002	ZONISAMIDE	ZONISAMIDE	CAPSULE;ORAL	50MG	No	No
003	ZONISAMIDE	ZONISAMIDE	CAPSULE;ORAL	25MG	No	No

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

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	Approval date
A077636-001	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22
A077636-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27
A077636-003	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077636-001	AB
A077636-002	AB
A077636-003	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077636-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077636-003	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077636-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077636-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077636-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077636-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077636-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077636-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077636-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077636-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077636-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077636-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077636-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077636-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077636-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077636-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077636-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077636-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077636-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077636-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077636-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077636-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077636-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077636-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077636-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077636-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077636-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077636-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077636-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077636-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077636-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077636-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077636-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077636-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077636-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077636-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077636-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077636-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077636-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077636-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077636-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077636-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077636-001	AB	1	`8072bd15b7f6…`

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 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
zonisamide	ZONISAMIDE	Cipla USA Inc.	e8f368cb-6a07-4178-95fa-1d5a209171ed	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	467a73f0-1cd1-46bf-83b3-ee38badb761c	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Sun Pharmaceutical Industries, Inc.	3164d438-90bf-420a-9a56-5498b987f91c	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	50bb1a0a-a66d-4a13-a456-a10c1b8c8e94	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	597f0a0b-e162-497c-9871-f2b73ebad245	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	BluePoint Laboratories	345efcc4-6a36-4ddf-8b6c-9c6c844dab0a	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Aurobindo Pharma Limited	ab0631ca-5339-4570-bc27-f1dd92de1d6f	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	1a859304-804a-4588-9961-c2e6ae09aadb	2025-11-26	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Glenmark Pharmaceuticals Inc., USA	fe15e56e-8b86-4a65-825c-31d37dd81612	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	AvPAK	b20a51ef-255e-1eb0-c0e1-461cde46b887	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	33b84aaa-044d-4c15-bb21-d1ce8674eec9	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	5000f95c-c78d-4150-9a69-0ee2943cf2c3	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Preferred Pharmaceuticals, Inc.	53ecba6c-0de4-4e11-81d5-6deac79accd5	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonegran	ZONISAMIDE	Advanz Pharma (US) Corp.	d12de43e-3ac3-4335-bc85-70d7366a91eb	2025-09-12	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	REMEDYREPACK INC.	40094d96-e979-4b3e-840f-a96677480f96	2025-08-05	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Preferred Pharmaceuticals Inc	061fdccc-d08e-4e42-8a32-54afb6c89701	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	994e3ce0-f30b-47b1-aa42-b1ed37fb7c12	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE
Zonisamide	ZONISAMIDE	Direct_Rx	35bcaee1-001f-82da-e063-6394a90a4a0f	2025-05-22	Warnings, Adverse reactions	Name fallback brand name: Zonisamide generic name: ZONISAMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-843	ZONISAMIDE	ZONISAMIDE	Aidarex Pharmaceuticals LLC	ANDA	Current
55648-945	ZONISAMIDE	ZONISAMIDE	WOCKHARDT LIMITED	ANDA	Current
55648-946	ZONISAMIDE	ZONISAMIDE	WOCKHARDT LIMITED	ANDA	Current
55648-990	ZONISAMIDE	ZONISAMIDE	WOCKHARDT LIMITED	ANDA	Current
61919-749	ZONISAMIDE	ZONISAMIDE	DIRECT RX	ANDA	Current
61919-749	ZONISAMIDE	ZONISAMIDE	DIRECT RX	ANDA	Current
63629-5008	ZONISAMIDE	ZONISAMIDE	Bryant Ranch Prepack	ANDA	Current
64679-945	ZONISAMIDE	ZONISAMIDE	Wockhardt USA LLC.	ANDA	Current
64679-946	ZONISAMIDE	ZONISAMIDE	Wockhardt USA LLC.	ANDA	Current
64679-990	ZONISAMIDE	ZONISAMIDE	Wockhardt USA LLC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24160	ORIG	2008-02-01
31268	ORIG	2005-12-28