Application 077645

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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	25MG	No	No
003	ZONISAMIDE	ZONISAMIDE	CAPSULE;ORAL	50MG	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
A077645-001	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22
A077645-002	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29
A077645-003	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077645-001	AB
A077645-002	AB
A077645-003	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	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`8072bd15b7f6…`

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
2026-02-19 14:30 UTC	2026-02	A077645-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077645-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077645-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077645-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077645-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077645-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077645-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077645-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077645-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077645-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	597f0a0b-e162-497c-9871-f2b73ebad245	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077645 application number: ANDA077645 ndc (product): 70518-3224
Zonisamide	ZONISAMIDE	Aurobindo Pharma Limited	ab0631ca-5339-4570-bc27-f1dd92de1d6f	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077645 application number: ANDA077645 ndc (product): 59651-380 ndc (product): 59651-378 ndc (product): 59651-379
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	994e3ce0-f30b-47b1-aa42-b1ed37fb7c12	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077645 application number: ANDA077645

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-288	Zonisamide	Zonisamide	Dr. Reddy's Laboratories	ANDA	Current
55111-402	Zonisamide	Zonisamide	Dr. Reddy's Laboratories	ANDA	Current
55111-403	Zonisamide	Zonisamide	Dr. Reddy's Laboratories	ANDA	Current
59651-378	Zonisamide	Zonisamide	Aurobindo Pharma Limited	ANDA	Current
59651-378	Zonisamide	Zonisamide	Aurobindo Pharma Limited	ANDA	Current
59651-378	Zonisamide	Zonisamide	Aurobindo Pharma Limited	ANDA	Current
59651-379	Zonisamide	Zonisamide	Aurobindo Pharma Limited	ANDA	Current
59651-379	Zonisamide	Zonisamide	Aurobindo Pharma Limited	ANDA	Current
59651-379	Zonisamide	Zonisamide	Aurobindo Pharma Limited	ANDA	Current
59651-380	Zonisamide	Zonisamide	Aurobindo Pharma Limited	ANDA	Current
59651-380	Zonisamide	Zonisamide	Aurobindo Pharma Limited	ANDA	Current
59651-380	Zonisamide	Zonisamide	Aurobindo Pharma Limited	ANDA	Current
70518-3224	Zonisamide	Zonisamide	REMEDYREPACK INC.	ANDA	Current
70518-3224	Zonisamide	Zonisamide	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24164	ORIG	2008-02-01
9072	ORIG	2005-12-28