Application 079206

Type: ANDA
Sponsor: FOSUN PHARMA

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079206-001	TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE / ORAL			2009-10-14
A079206-002	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE / ORAL			2009-10-14

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`74a2ff9319b5…`

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 3 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	REMEDYREPACK INC.	2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Upsher-Smith Laboratories, LLC	691d276c-9cc1-4d39-828f-0f44d7ef6328	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Vitruvias Therapeutics, Inc.	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Glenmark Pharmaceuticals Inc., USA	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: TOPIRAMATE generic name: TOPIRAMATE
topiramate	TOPIRAMATE	REMEDYREPACK INC.	149d20de-f262-4567-aa97-d4d28a1653cb	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Coupler LLC	50b10a3d-883c-8891-e063-6394a90a86a1	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Glenmark Pharmaceuticals Inc., USA	872927eb-0b61-44bb-9892-3c700b6f2181	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Quallent Pharmaceuticals Health LLC	9dae6824-6913-42de-b98a-cdcb0d3b4a46	2026-04-25	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	e4886adf-199d-4b19-a4ef-75f8f94cb54e	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Ajanta Pharma USA Inc.	b94629e3-ae2e-473e-b2f5-06e32ee19aa9	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	67dcdd6e-48bc-418e-a887-805929d83ce0	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Glenmark Pharmaceuticals Inc., USA	35312f49-decf-428d-bf5f-4215b762ed3c	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Unichem Pharmaceuticals (USA), Inc.	6ee00e82-799d-445e-b658-a9712c49a28e	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advagen Pharma Ltd	48169bbc-4fb2-4bc4-9bdd-de71bf7722df	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Teva Pharmaceuticals, Inc.	4f20155f-05b9-40ec-af34-3b58aa8d60d4	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	f72774dd-c7eb-41f9-9837-02baf77cc523	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Lupin Pharmaceuticals, Inc.	e310afcd-1260-434e-a994-34549c789d99	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Aurobindo Pharma Limited	32b48ea0-a215-43b8-83b4-a5435a686d68	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Aurobindo Pharma Limited	d1588c37-9da9-4ccb-b78a-64234938a115	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: TOPIRAMATE generic name: TOPIRAMATE

Reported adverse events (FAERS/openFDA)#

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