Application 077625

Type: ANDA
Sponsor: ZYDUS PHARMS USA

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 42.

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
A077625-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16
A077625-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16
A077625-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077625-001	AB
A077625-002	AB
A077625-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077625-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077625-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077625-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077625-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077625-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077625-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077625-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077625-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077625-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077625-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077625-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077625-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077625-001	AB	1	`1e350fbaab3a…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	40094d96-e979-4b3e-840f-a96677480f96	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	33b84aaa-044d-4c15-bb21-d1ce8674eec9	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	5000f95c-c78d-4150-9a69-0ee2943cf2c3	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Preferred Pharmaceuticals Inc	061fdccc-d08e-4e42-8a32-54afb6c89701	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Direct_Rx	35bcaee1-001f-82da-e063-6394a90a4a0f	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Zydus Lifesciences Limited	4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f	2024-08-16		Exact identifier application applno (ANDA): 077625 application number: ANDA077625 ndc (product): 70771-1144 ndc (product): 70771-1142 ndc (product): 70771-1143
Zonisamide	ZONISAMIDE	Advanced Rx Pharmacy of Tennessee, LLC	19b059f0-a08a-f75a-e063-6294a90a57db	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Viona Pharmaceuticals Inc	5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625 ndc (product): 72578-042 ndc (product): 72578-040 ndc (product): 72578-041

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-212	Zonisamide	Zonisamide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-212	Zonisamide	Zonisamide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-212	Zonisamide	Zonisamide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-213	Zonisamide	Zonisamide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-213	Zonisamide	Zonisamide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-213	Zonisamide	Zonisamide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-214	Zonisamide	Zonisamide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-214	Zonisamide	Zonisamide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-214	Zonisamide	Zonisamide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1142	Zonisamide	Zonisamide	Zydus Lifesciences Limited	ANDA	Current
70771-1142	Zonisamide	Zonisamide	Cadila Healthcare Limited	ANDA	Current
70771-1142	Zonisamide	Zonisamide	Cadila Healthcare Limited	ANDA	Current
70771-1142	Zonisamide	Zonisamide	Cadila Healthcare Limited	ANDA	Current
70771-1143	Zonisamide	Zonisamide	Zydus Lifesciences Limited	ANDA	Current
70771-1143	Zonisamide	Zonisamide	Cadila Healthcare Limited	ANDA	Current
70771-1143	Zonisamide	Zonisamide	Cadila Healthcare Limited	ANDA	Current
70771-1143	Zonisamide	Zonisamide	Cadila Healthcare Limited	ANDA	Current
70771-1144	Zonisamide	Zonisamide	Zydus Lifesciences Limited	ANDA	Current
70771-1144	Zonisamide	Zonisamide	Cadila Healthcare Limited	ANDA	Current
70771-1144	Zonisamide	Zonisamide	Cadila Healthcare Limited	ANDA	Current
70771-1144	Zonisamide	Zonisamide	Cadila Healthcare Limited	ANDA	Current
72578-040	Zonisamide	Zonisamide	Viona Pharmaceuticals Inc	ANDA	Current
72578-040	Zonisamide	Zonisamide	Viona Pharmaceuticals Inc	ANDA	Current
72578-040	Zonisamide	Zonisamide	Viona Pharmaceuticals Inc	ANDA	Current
72578-041	Zonisamide	Zonisamide	Viona Pharmaceuticals Inc	ANDA	Current
72578-041	Zonisamide	Zonisamide	Viona Pharmaceuticals Inc	ANDA	Current
72578-041	Zonisamide	Zonisamide	Viona Pharmaceuticals Inc	ANDA	Current
72578-042	Zonisamide	Zonisamide	Viona Pharmaceuticals Inc	ANDA	Current
72578-042	Zonisamide	Zonisamide	Viona Pharmaceuticals Inc	ANDA	Current
72578-042	Zonisamide	Zonisamide	Viona Pharmaceuticals Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44620	ORIG	2008-02-01