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 7 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	b353e7fb-b976-96d8-e053-2995a90a110a	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Zydus Lifesciences Limited	57016639-89fe-43ad-89c4-5e7a756dddec	2024-08-14		Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	654f7c48-8c5d-4b97-88d6-397696f82b6a	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	1ef1c408-30f7-51ee-e063-6394a90ac880	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	e9cb3c29-098c-405f-a200-b436ac7fa1a2	2024-07-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals, Inc.	4a656a9f-8eb8-69b7-e054-00144ff8d46c	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	9ddb8451-a455-87ec-e053-2995a90a5e5e	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	816566bf-b909-606f-e053-2a91aa0ab8c9	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	87dc077b-2c84-522b-e053-2995a90a68bc	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	1a16d6a9-3dd1-ede8-e063-6294a90afe75	2024-06-04	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	78ef4e4e-d391-4417-952b-06202d5000d8	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	10a9e6fa-4d55-6b5c-e063-6294a90a608c	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	A-S Medication Solutions	93da6674-14dc-4c8d-9424-03e4b2b41479	2023-12-12	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	A-S Medication Solutions	f7f2d1bc-9c65-4798-826f-6902b3ec81dc	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Zydus Lifesciences Limited	9a943af0-1c6d-43c2-830a-f303baa16124	2023-11-08		Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Zydus Lifesciences Limited	57b5d67b-b29b-4c18-a53d-51d5374f3be3	2023-09-28		Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	8bd03bb2-3b9b-4707-a9a4-5618ddc3832f	2023-07-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	2917ba32-3355-4d64-966a-8518e6fafdbe	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Proficient Rx LP	80481455-7ad7-4f44-8113-b8b61d8581a0	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Proficient Rx LP	a30c583a-4b0a-43a6-ae76-19b1a5e916ca	2022-10-01	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.