Application 079153

Type: ANDA
Sponsor: TORRENT PHARMS

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 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	Approval date
A079153-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27
A079153-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27
A079153-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27
A079153-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A079153-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079153-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079153-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079153-004	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A079153-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079153-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079153-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079153-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079153-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079153-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079153-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079153-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079153-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079153-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079153-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079153-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079153-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079153-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079153-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079153-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079153-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079153-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079153-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079153-004	AB	1	`ea99ee380514…`

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 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 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
43063-094	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-094	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-538	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-538	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
52959-441	TOPIRAMATE	topiramate	H.J. Harkins Company, Inc.	ANDA	Current
52959-994	TOPIRAMATE	topiramate	H.J. Harkins Company, Inc.	ANDA	Current
61919-185	TOPIRAMATE	topiramate tablet	DIRECT RX	ANDA	Current
61919-825	TOPIRAMATE	TOPIRAMATE	DIRECT RX	ANDA	Current
61919-825	TOPIRAMATE	TOPIRAMATE	DIRECT RX	ANDA	Current
68788-9730	TOPIRAMATE	topiramate	Preferred Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44402	ORIG	2009-04-14
9227	ORIG	2009-04-01