Application 077637

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZONISAMIDE	ZONISAMIDE	CAPSULE;ORAL	25MG	No	No
002	ZONISAMIDE	ZONISAMIDE	CAPSULE;ORAL	50MG	No	No
003	ZONISAMIDE	ZONISAMIDE	CAPSULE;ORAL	100MG	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	Approval date
A077637-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22
A077637-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22
A077637-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077637-002	ZONISAMIDE	50MG	CAPSULE / ORAL	2005-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077637-003	ZONISAMIDE	100MG	CAPSULE / ORAL	2005-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077637-001	ZONISAMIDE	25MG	CAPSULE / ORAL	2005-12-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077637-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077637-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077637-003	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A077637-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077637-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077637-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077637-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077637-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077637-003	AB	1	`ea99ee380514…`

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6725	Zonisamide	zonisamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6725	Zonisamide	zonisamide	Mylan Pharmaceuticals Inc	ANDA	Current
0378-6726	Zonisamide	zonisamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6726	Zonisamide	zonisamide	Mylan Pharmaceuticals Inc	ANDA	Current
0378-6727	Zonisamide	zonisamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6727	Zonisamide	zonisamide	Mylan Pharmaceuticals Inc	ANDA	Current
0615-1379	Zonisamide	zonisamide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43063-575	Zonisamide	zonisamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-575	Zonisamide	zonisamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
51079-768	Zonisamide	zonisamide	Mylan Institutional Inc.	ANDA	Current
55700-204	Zonisamide	zonisamide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44622	ORIG	2008-02-01
9069	ORIG	2005-12-28