Application 078877

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPIRAMATE	TOPIRAMATE	CAPSULE;ORAL	15MG	No	No
002	TOPIRAMATE	TOPIRAMATE	CAPSULE;ORAL	25MG	No	No
003	TOPIRAMATE	TOPIRAMATE	CAPSULE;ORAL	50MG	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	TE codes	Approval date
A078877-001	TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14
A078877-002	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14
A078877-003	TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078877-001	AB
A078877-002	AB
A078877-003	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 3 · 97 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	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	A078877-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078877-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078877-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078877-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078877-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078877-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078877-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078877-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078877-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078877-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078877-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078877-003	AB	1	`a50c72e98297…`

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
topiramate	TOPIRAMATE	REMEDYREPACK INC.	0c0a6774-e234-47a5-866e-462cfd99744c	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078877 application number: ANDA078877
topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	e4886adf-199d-4b19-a4ef-75f8f94cb54e	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078877 application number: ANDA078877 ndc (product): 68382-004 ndc (product): 68382-005
topiramate	TOPIRAMATE	Zydus Lifesciences Limited	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	2024-10-25		Exact identifier application applno (ANDA): 078877 application number: ANDA078877 ndc (product): 65841-651 ndc (product): 65841-652

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-651	topiramate	topiramate	Cadila Healthcare Limited	ANDA	Current
65841-651	topiramate	topiramate	Cadila Healthcare Limited	ANDA	Current
65841-651	topiramate	topiramate	Zydus Lifesciences Limited	ANDA	Current
65841-651	topiramate	topiramate	Cadila Healthcare Limited	ANDA	Current
65841-652	topiramate	topiramate	Cadila Healthcare Limited	ANDA	Current
65841-652	topiramate	topiramate	Cadila Healthcare Limited	ANDA	Current
65841-652	topiramate	topiramate	Zydus Lifesciences Limited	ANDA	Current
65841-652	topiramate	topiramate	Cadila Healthcare Limited	ANDA	Current
68382-004	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-004	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-004	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-004	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-004	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-005	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-005	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-005	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-005	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-005	topiramate	topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current