Application 077869

Type: ANDA
Sponsor: INVAGEN PHARMS

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
A077869-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31
A077869-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31
A077869-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077869-001	AB
A077869-002	AB
A077869-003	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	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`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	A077869-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077869-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077869-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077869-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077869-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077869-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077869-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077869-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077869-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077869-001	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 · 6 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	Exact identifier application applno (ANDA): 077869 application number: ANDA077869 ndc (product): 69097-861
Zonisamide	ZONISAMIDE	AvPAK	b20a51ef-255e-1eb0-c0e1-461cde46b887	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869 ndc (product): 50268-816
zonisamide	ZONISAMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	226d917a-33de-48cc-baf6-bd6a20668341	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869 ndc (product): 0615-8266
Zonisamide	ZONISAMIDE	American Health Packaging	7cdd96c4-3263-4c28-86c0-3c24bcef16c1	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869 ndc (product): 60687-230
zonisamide	ZONISAMIDE	Bryant Ranch Prepack	64bd9d6f-8cc0-4151-a78d-9f1437b36875	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869 ndc (product): 71335-0486
Zonisamide	ZONISAMIDE	Exelan Pharmaceuticals, Inc.	24284954-0c29-458f-a9f8-97a7ad418ca7	2021-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869 ndc (product): 76282-227 ndc (product): 76282-228 ndc (product): 76282-226

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8266	zonisamide	zonisamide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8266	zonisamide	zonisamide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8266	zonisamide	zonisamide	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
31722-228	Zonisamide	Zonisamide	Camber Pharmaceuticals	ANDA	Current
50268-816	Zonisamide	Zonisamide	AvPAK	ANDA	Current
50268-816	Zonisamide	Zonisamide	AvPAK	ANDA	Current
50268-816	Zonisamide	Zonisamide	AvPAK	ANDA	Current
53217-301	zonisamide	zonisamide	Aidarex Pharmaceuticals LLC	ANDA	Current
60687-230	Zonisamide	Zonisamide	American Health Packaging	ANDA	Current
60687-230	Zonisamide	Zonisamide	American Health Packaging	ANDA	Current
60687-230	Zonisamide	Zonisamide	American Health Packaging	ANDA	Current
60687-230	Zonisamide	Zonisamide	American Health Packaging	ANDA	Current
69097-861	zonisamide	zonisamide	Cipla USA Inc.	ANDA	Current
69097-861	zonisamide	zonisamide	Cipla USA Inc.	ANDA	Current
70518-3180	zonisamide	zonisamide	REMEDYREPACK INC.	ANDA	Current
71335-0486	zonisamide	zonisamide	Bryant Ranch Prepack	ANDA	Current
71335-0486	zonisamide	zonisamide	Bryant Ranch Prepack	ANDA	Current
71335-0486	zonisamide	zonisamide	Bryant Ranch Prepack	ANDA	Current
76282-226	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-226	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-226	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-227	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-227	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-227	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-228	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-228	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-228	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-228	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-228	Zonisamide	Zonisamide	Exelan Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44628	ORIG	2008-02-01