Application 077634

Type: ANDA
Sponsor: SUN PHARM INDS (IN)

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 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	Approval date
A077634-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	2006-03-17
A077634-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	2006-03-17
A077634-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	2006-03-17

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077634-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077634-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077634-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077634-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077634-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077634-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077634-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077634-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077634-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077634-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077634-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077634-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077634-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077634-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077634-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077634-001	AB	1	`4b0b4de00fa7…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	467a73f0-1cd1-46bf-83b3-ee38badb761c	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634 ndc (product): 71335-0962
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634 ndc (product): 63629-3293
Zonisamide	ZONISAMIDE	Sun Pharmaceutical Industries, Inc.	3164d438-90bf-420a-9a56-5498b987f91c	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634 ndc (product): 62756-258 ndc (product): 62756-259 ndc (product): 62756-260
Zonisamide	ZONISAMIDE	Preferred Pharmaceuticals, Inc.	53ecba6c-0de4-4e11-81d5-6deac79accd5	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634 ndc (product): 68788-7438
Zonisamide	ZONISAMIDE	Direct_Rx	e64b78d8-79de-337b-e053-2a95a90a4861	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634 ndc (product): 72189-374
Zonisamide	ZONISAMIDE	Proficient Rx LP	812582ce-fc7e-44b1-a428-7faa3701c1b8	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634 ndc (product): 63187-897

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-155	ZONISAMIDE	ZONISAMIDE	Rebel Distributors Corp	ANDA	Current
21695-654	ZONISAMIDE	ZONISAMIDE	Rebel Distributors Corp	ANDA	Current
35356-143	ZONISAMIDE	ZONISAMIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-143	ZONISAMIDE	ZONISAMIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-143	ZONISAMIDE	ZONISAMIDE	Quality Care Products LLC	ANDA	Current
35356-143	ZONISAMIDE	ZONISAMIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
43063-932	Zonisamide	Zonisamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-932	Zonisamide	Zonisamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-932	Zonisamide	Zonisamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-932	Zonisamide	Zonisamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-932	Zonisamide	Zonisamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-932	Zonisamide	Zonisamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
51407-137	Zonisamide	Zonisamide	Golden State Medical Supply Inc	ANDA	Current
51407-137	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-137	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-137	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-137	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-138	Zonisamide	Zonisamide	Golden State Medical Supply Inc	ANDA	Current
51407-138	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-138	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-138	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-138	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-139	Zonisamide	Zonisamide	Golden State Medical Supply Inc	ANDA	Current
51407-139	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-139	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-139	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
51407-139	Zonisamide	Zonisamide	Golden State Medical Supply, Inc.	ANDA	Current
61919-275	ZONISAMIDE	ZONISAMIDE	DirectRX	ANDA	Current
61919-917	ZONISAMIDE	ZONISAMIDE	DIRECT RX	ANDA	Current
61919-917	ZONISAMIDE	ZONISAMIDE	Direct_Rx	ANDA	Current
61919-917	ZONISAMIDE	ZONISAMIDE	Direct_Rx	ANDA	Current
61919-917	ZONISAMIDE	ZONISAMIDE	Direct_Rx	ANDA	Current
61919-917	ZONISAMIDE	ZONISAMIDE	Direct_Rx	ANDA	Current
62756-258	Zonisamide	Zonisamide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-258	Zonisamide	Zonisamide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-259	Zonisamide	Zonisamide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-259	Zonisamide	Zonisamide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-260	Zonisamide	Zonisamide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-260	Zonisamide	Zonisamide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63187-897	Zonisamide	Zonisamide	Proficient Rx LP	ANDA	Current
63187-897	Zonisamide	Zonisamide	Proficient Rx LP	ANDA	Current
63187-897	Zonisamide	Zonisamide	Proficient Rx LP	ANDA	Current
63187-897	Zonisamide	Zonisamide	Proficient Rx LP	ANDA	Current
63629-3293	Zonisamide	Zonisamide	Bryant Ranch Prepack	ANDA	Current
63629-3293	ZONISAMIDE	ZONISAMIDE	Bryant Ranch Prepack	ANDA	Current
63629-4565	ZONISAMIDE	ZONISAMIDE	Bryant Ranch Prepack	ANDA	Current
68788-7438	Zonisamide	Zonisamide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7438	Zonisamide	Zonisamide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7438	Zonisamide	Zonisamide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7438	Zonisamide	Zonisamide	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1701	Zonisamide	Zonisamide	REMEDYREPACK INC.	ANDA	Current
70518-1701	Zonisamide	Zonisamide	REMEDYREPACK INC.	ANDA	Current
70518-1701	Zonisamide	Zonisamide	REMEDYREPACK INC.	ANDA	Current
70518-1701	Zonisamide	Zonisamide	REMEDYREPACK INC.	ANDA	Current
71335-0962	Zonisamide	Zonisamide	Bryant Ranch Prepack	ANDA	Current
71335-0962	Zonisamide	Zonisamide	Bryant Ranch Prepack	ANDA	Current
71335-0962	Zonisamide	Zonisamide	Bryant Ranch Prepack	ANDA	Current
72189-374	Zonisamide	Zonisamide	Direct_Rx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24159	ORIG	2008-02-01