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 5 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	A-S Medication Solutions	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	A-S Medication Solutions	c6918801-f22c-4ba4-a396-da484d4334ca	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NCS HealthCare of KY, LLC dba Vangard Labs	444464fb-6a95-4e10-99a7-fdbc7dbb4c48	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Cardinal Health 107, LLC	e5bc696e-040d-4d3e-b38c-9548a38fa936	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	be42ed09-350c-4e8a-aff4-6afb242dd599	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Preferred Pharmaceuticals, Inc.	2b6b0642-fb91-4641-9c51-d3be2021992b	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	American Health Packaging	1af94c80-2b17-409a-98f6-ce00f942351d	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	83558f89-1adb-4d81-b19b-68721d48034b	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Preferred Pharmaceuticals, Inc.	d8454fdf-7b34-49c0-b130-732e39b774b2	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Major Pharmaceuticals	6fb00bd8-c49e-46ef-9d6b-1b602e1d11d8	2025-08-25	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	A-S Medication Solutions	674c2c2e-014a-43a1-91a7-7214ffc4b1d7	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals, Inc.	490f109f-30cb-0790-e054-00144ff88e88	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	9e516204-8f39-43c9-9f7e-d9777586f321	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	e39d2549-b489-426d-b576-741537e112e7	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	XLCare Pharmaceuticals, Inc.	546103e1-ea6e-466b-b0de-b1ff8c494512	2025-07-02	Warnings, Adverse reactions	Name fallback brand name: TOPIRAMATE generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	A-S Medication Solutions	f16b14a2-297f-4adb-8d7a-5f43785faef7	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Camber Pharmaceuticals, Inc.	cefbc5f4-ef5f-4732-ab96-a69a183f0b6b	2025-05-22	Warnings, Adverse reactions	Name fallback brand name: TOPIRAMATE generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	49701840-5a32-4ac1-8b07-5c61decacb95	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	bf732c34-9078-496a-8093-f68594e76fcb	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	02cac021-e135-483f-bb5d-f3696eef0682	2025-05-01	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.