Application 077651

Type: ANDA
Sponsor: GLENMARK GENERICS

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	TE codes	Approval date
A077651-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30
A077651-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30
A077651-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077651-001	AB
A077651-002	AB
A077651-003	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	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`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	A077651-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077651-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077651-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077651-001	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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	50bb1a0a-a66d-4a13-a456-a10c1b8c8e94	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651
Zonisamide	ZONISAMIDE	BluePoint Laboratories	345efcc4-6a36-4ddf-8b6c-9c6c844dab0a	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651 ndc (product): 68001-244 ndc (product): 68001-242 ndc (product): 68001-243
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	1a859304-804a-4588-9961-c2e6ae09aadb	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651
Zonisamide	ZONISAMIDE	Glenmark Pharmaceuticals Inc., USA	fe15e56e-8b86-4a65-825c-31d37dd81612	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651 ndc (product): 68462-129 ndc (product): 68462-130 ndc (product): 68462-128
Zonisamide	ZONISAMIDE	Proficient Rx LP	85321a9a-08d9-49e4-8c79-86ecfc536613	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651 ndc (product): 63187-583

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2174	Zonisamide	Zonisamide	A-S Medication Solutions	ANDA	Current
61919-591	Zonisamide	Zonisamide	Direct Rx	ANDA	Current
61919-775	Zonisamide	Zonisamide	Direct Rx	ANDA	Current
61919-775	ZONISAMIDE	ZONISAMIDE	Direct_Rx	ANDA	Current
61919-775	ZONISAMIDE	ZONISAMIDE	Direct_Rx	ANDA	Current
61919-775	ZONISAMIDE	ZONISAMIDE	Direct_Rx	ANDA	Current
63187-583	Zonisamide	Zonisamide	Proficient Rx LP	ANDA	Current
63187-583	Zonisamide	Zonisamide	Proficient Rx LP	ANDA	Current
63187-583	Zonisamide	Zonisamide	Proficient Rx LP	ANDA	Current
68001-242	Zonisamide	Zonisamide	BluePoint Laboratories	ANDA	Current
68001-242	Zonisamide	Zonisamide	BluePoint Laboratories	ANDA	Current
68001-242	Zonisamide	Zonisamide	BluePoint Laboratories	ANDA	Current
68001-243	Zonisamide	Zonisamide	BluePoint Laboratories	ANDA	Current
68001-243	Zonisamide	Zonisamide	BluePoint Laboratories	ANDA	Current
68001-243	Zonisamide	Zonisamide	BluePoint Laboratories	ANDA	Current
68001-244	Zonisamide	Zonisamide	BluePoint Laboratories	ANDA	Current
68001-244	Zonisamide	Zonisamide	BluePoint Laboratories	ANDA	Current
68001-244	Zonisamide	Zonisamide	BluePoint Laboratories	ANDA	Current
68071-4152	Zonisamide	Zonisamide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4152	Zonisamide	Zonisamide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-128	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-128	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-128	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-128	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-128	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-128	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-129	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-129	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-129	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-129	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-129	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-129	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-130	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-130	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-130	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-130	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-130	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-130	Zonisamide	Zonisamide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
71335-0125	Zonisamide	Zonisamide	Bryant Ranch Prepack	ANDA	Current
71335-0125	Zonisamide	Zonisamide	Bryant Ranch Prepack	ANDA	Current
71335-0125	Zonisamide	Zonisamide	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44627	ORIG	2008-02-01