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 43.

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`caaa826d4ba7…`
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…`

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 6 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	Bryant Ranch Prepack	c320999e-b940-44d8-bf31-2fb78835ac2d	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	A-S Medication Solutions	ea0bcab1-cfe1-491c-875e-8c865449557e	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	073d075d-d019-4834-b55d-9b9587914975	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Cipla USA Inc.	4087eb3c-96e9-4d0a-b80b-663e1c86d256	2025-04-14	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	EXELAN PHARMACEUTICALS INC.	690baf58-1ec9-463e-99b7-d601362ea56b	2025-04-14	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Cipla USA Inc.	ca4ec248-285d-4066-8f89-5ed0c538c4c9	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	30ca2fce-4e4c-439e-e063-6294a90af076	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	bbf0f882-1dcc-415d-82bb-acc64f4dc2bc	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	288d6b40-8c87-4f16-85a7-86166b5ac77f	2025-02-14	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	2cf7ce9e-afc2-f94e-e063-6394a90a35d0	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	521be3f1-3ee7-45c7-9f0c-17e08b6c8fca	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	d63b64dd-b420-4283-9bac-92ba43c9f429	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	eca774cf-2e4e-7642-e053-2a95a90a847d	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	d8dff98f-185e-77ba-e053-2995a90aed2f	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	f16065c0-9949-9ac4-e053-2995a90a3b02	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	f781ada8-f90d-b233-e053-6394a90a87ff	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Zydus Lifesciences Limited	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	2024-10-25		Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	A-S Medication Solutions	8706a35d-5c39-4daf-b83a-65f3d630e043	2024-08-21	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	61390be3-7553-4cb5-b5da-7571ed7d4b17	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	ffaacad8-4594-45a8-b292-02a84cd0c35b	2024-08-20	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.

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