Application 215414

Type: ANDA
Sponsor: ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	25MG	No	No
002	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	50MG	No	No
003	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	100MG	No	No
004	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215414-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26
A215414-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26
A215414-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26
A215414-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A215414-001	AB
A215414-002	AB
A215414-003	AB
A215414-004	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.

Product history page 1 of 4 · 136 observed 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
2026-08-18 06:07:40	2026-07	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215414-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215414-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215414-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215414-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215414-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215414-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215414-004	AB	1	`d8e5a09893c0…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOPIRAMATE	TOPIRAMATE	XLCare Pharmaceuticals, Inc.	546103e1-ea6e-466b-b0de-b1ff8c494512	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215414 application number: ANDA215414
TOPIRAMATE	TOPIRAMATE	Camber Pharmaceuticals, Inc.	cefbc5f4-ef5f-4732-ab96-a69a183f0b6b	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215414 application number: ANDA215414 ndc (product): 31722-184 ndc (product): 31722-182 ndc (product): 31722-181 ndc (product): 31722-183

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-181	TOPIRAMATE	Topiramate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-182	TOPIRAMATE	Topiramate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-183	TOPIRAMATE	Topiramate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-184	TOPIRAMATE	Topiramate	Camber Pharmaceuticals, Inc.	ANDA	Current
43602-457	TOPIRAMATE	Topiramate	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-458	TOPIRAMATE	Topiramate	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-459	TOPIRAMATE	Topiramate	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-460	TOPIRAMATE	Topiramate	Ascent Pharmaceuticals, Inc.	ANDA	Current