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 4 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	5424d59e-74f1-4c3c-b737-79e9776e0b60	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Camber Pharmaceuticals, Inc.	dbc52b16-b93d-4d83-942b-485c502db1fa	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: TOPIRAMATE generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Ascend Laboratories, LLC	7bc4ec7a-9b83-4842-9057-e1a804b2596d	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: TOPIRAMATE generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Ascend Laboratories, LLC	035bf713-1642-4215-83ec-0ed07c29f92c	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: TOPIRAMATE generic name: TOPIRAMATE
Topamax	TOPIRAMATE	Janssen Pharmaceuticals, Inc.	21628112-0c47-11df-95b3-498d55d89593	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	C	164cb1f7-1a41-675f-e063-6294a90ae0dd	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	4b1d3130-cf3c-d7da-e063-6294a90a6079	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	A-S Medication Solutions	7f1e4475-6326-47a3-a317-b04b74b7c109	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	A-S Medication Solutions	55e71f43-1cd5-4efc-9641-fda0a09c30f0	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Dr. Reddys Laboratories Inc.	f07d81bc-5090-fbc5-2945-557cf002849c	2026-02-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	68b22d22-c2d3-4e90-b302-56f7cb731427	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	AvKARE	25b377f7-ea89-fb56-e063-6394a90a239d	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Northwind Health Company, LLC	afd4c2b9-b80c-b43a-e053-2995a90ac923	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Northwind Health Company, LLC	ca45d478-7214-5bc7-e053-2995a90aa601	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Northwind Health Company, LLC	ae63e0e2-ceb1-4cc7-88fa-92cfa4516960	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Northwind Health Company, LLC	f3321dc5-0fb7-0d12-e053-2a95a90a9694	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Northwind Health Company, LLC	ffd7be08-050e-dfcb-e053-6394a90ad286	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Ascend Laboratories, LLC	cb966bcb-3af7-4dbe-b540-58d473b891e5	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	1f327383-beb3-4d15-add6-5f1c749f2b3f	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Eprontia	TOPIRAMATE	Azurity Pharmaceuticals, Inc.	e2a4df59-fead-4a01-9021-9eda02c48010	2025-11-13	Warnings, Adverse reactions	Name fallback 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