Application 218642

Type: ANDA
Sponsor: SENORES PHARMS

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
A218642-001	TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE / ORAL	AB		2024-10-10
A218642-002	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE / ORAL	AB		2024-10-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A218642-001	AB
A218642-002	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.

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	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218642-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2024-10-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218642-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2024-10-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218642-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218642-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218642-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218642-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218642-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218642-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218642-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218642-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218642-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218642-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218642-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218642-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218642-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218642-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218642-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218642-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218642-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218642-002	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218642-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218642-002	AB	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218642-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218642-002	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 8 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Asclemed USA, Inc.	4e476c33-3590-4c6f-981d-915623cdacf0	2022-09-09	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	e382a731-ef73-4990-bc74-ffc3a91ff3ba	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	57ac12ed-27f0-4f5c-96ae-a7433714b429	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Aphena Pharma Solutions - Tennessee, LLC	3b18b43c-0de2-4acf-b0d5-f1b601d496de	2021-05-03	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	e9c4e279-0ef9-4e96-8741-dfe7556953d9	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	a712d050-d5de-4685-a80a-548ab080fdb7	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8	2020-09-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Proficient Rx LP	cc918c0d-2b1e-4fa0-b4d3-9dbc28718018	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Proficient Rx LP	584e16c5-5ffb-4bfc-ba80-4340afd25e8e	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	7d6752ce-7a56-4b04-ab15-cbd40aa5cc94	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	efc0d85e-fddc-4122-85b2-da2d2cb2f9d8	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Proficient Rx LP	2d6d236b-9808-4e18-b521-e7435d1fd5cc	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Sun Pharmaceutical Industries, Inc.	2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef	2018-11-01	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.