Application 076575

Type: ANDA
Sponsor: TEVA

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 1.

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
A076575-001	TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE / ORAL			2009-04-17
A076575-002	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE / ORAL			2009-04-17

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 · 82 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	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL		2009-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL		2009-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076575-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076575-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076575-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076575-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076575-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076575-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076575-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076575-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076575-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076575-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076575-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076575-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076575-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076575-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076575-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076575-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076575-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076575-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076575-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076575-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076575-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076575-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076575-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076575-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076575-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076575-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076575-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076575-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076575-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076575-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076575-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076575-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076575-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076575-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076575-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076575-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076575-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076575-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076575-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076575-002	AB	1	`87673890dc5c…`

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 8 · 157 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	610d4df7-703f-4070-9adc-3e57ca05a2f1	2026-07-30	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	St. Mary's Medical Park Pharmacy	46a305cb-ab73-0bca-e063-6294a90a9b85	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
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	484c132f-3d3d-4218-b22f-82e9b56cc2f4	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Golden State Medical Supply, Inc.	163e9f2d-27be-6d3f-e063-6394a90a5884	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	bffcd213-4f09-4a5b-8ccb-591a68be402b	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	57462baf-2f32-4bde-9627-2214c8af9370	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7335	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7335	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7335	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7335	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7335	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7336	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7336	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7336	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7336	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7336	Topiramate	Topiramate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
53808-0932	Topiramate	TOPIRAMATE	State of Florida DOH Central Pharmacy	ANDA	Current
63629-6871	Topiramate	Topiramate	Bryant Ranch Prepack	ANDA	Current
63629-6871	Topiramate	Topiramate	Bryant Ranch Prepack	ANDA	Current
63629-6871	Topiramate	Topiramate	Bryant Ranch Prepack	ANDA	Current