Application 215663

Type: ANDA
Sponsor: AJANTA PHARMA LTD

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A215663-001	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-08-15
A215663-002	TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-08-15
A215663-003	TOPIRAMATE	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-08-15
A215663-004	TOPIRAMATE	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215663-001	AB1
A215663-002	AB1
A215663-003	AB1
A215663-004	AB1

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 2 · 80 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
2026-02-19 14:30 UTC	2026-02	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215663-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215663-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215663-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215663-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-08-15	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215663-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215663-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215663-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215663-004	AB1	1	`011fe1cb6892…`
2024-02-18 07:12 UTC	2024-02	A215663-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215663-002	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215663-003	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215663-004	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215663-001	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215663-002	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215663-003	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215663-004	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215663-001	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215663-002	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215663-003	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215663-004	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215663-001	AB1	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215663-002	AB1	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215663-003	AB1	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215663-004	AB1	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215663-001	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215663-002	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215663-003	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215663-004	AB1	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Ajanta Pharma USA Inc.	b94629e3-ae2e-473e-b2f5-06e32ee19aa9	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215663 application number: ANDA215663