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 44.

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079206-001	TOPIRAMATE	15MG	CAPSULE / ORAL	2009-10-14	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079206-002	TOPIRAMATE	25MG	CAPSULE / ORAL	2009-10-14	`3a93d1ddd44b…`

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 8 · 143 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	3f99b26b-79b9-4efb-aa2c-2868e1e126c8	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
QUDEXY XR	TOPIRAMATE	Upsher-Smith Laboratories, LLC	46f54677-3a22-4c38-9b92-923020164e15	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	REMEDYREPACK INC.	0c0a6774-e234-47a5-866e-462cfd99744c	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Coupler LLC	59f39dea-f29b-d6c6-e063-6294a90a5b74	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Coupler LLC	5826cb22-3559-171b-e063-6394a90ad594	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	c90d81a9-a87b-48b0-8cf1-172b82e30127	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	4833f2e8-16b7-406f-937a-55bc978bf92c	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	44095c2b-2e90-45d2-ab45-d0961c41550d	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	REMEDYREPACK INC.	7e0834ee-920b-496f-954d-f9d81c3ba2d6	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	b71c09c5-43dd-4d98-9ab6-0b0c99908cac	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	f8aaf403-0e15-4bbb-b88b-253d93439688	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Unit Dose Solutions, Inc.	562f3fec-489b-4662-e063-6294a90a4ea2	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	REMEDYREPACK INC.	0366164b-1846-443d-9564-dbe52d8d9b65	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	e846124d-e9e6-42c7-83f1-5df170d3f70b	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Coupler LLC	55f2aca4-b961-a746-e063-6294a90ae8ce	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	0cf388dc-d8f1-4478-bf5f-e64638ee5801	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	92637f92-9d7c-c246-e053-2995a90a0347	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	9221403c-467f-738e-e053-2995a90ac8fd	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	47ef2964-3a41-4bfd-86fb-d44560b9961f	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	8abe45eb-cc75-4625-ae3d-5b2a038c4907	2026-06-24	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.