Application 207382

Type: ANDA
Sponsor: ZYDUS PHARMS

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 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	TE codes	Approval date
A207382-001	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24
A207382-002	TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24
A207382-003	TOPIRAMATE	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24
A207382-004	TOPIRAMATE	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207382-001	AB1
A207382-002	AB1
A207382-003	AB1
A207382-004	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 4 · 150 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
2026-09-14 22:38:34	2026-08	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207382-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207382-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207382-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2017-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207382-004	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-10-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 150 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A207382-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207382-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207382-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207382-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207382-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207382-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207382-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207382-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207382-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207382-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207382-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207382-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207382-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207382-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207382-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207382-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207382-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207382-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207382-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207382-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207382-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207382-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207382-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207382-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207382-002	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207382-003	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207382-004	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207382-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207382-002	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207382-003	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207382-004	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207382-001	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207382-002	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207382-003	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207382-004	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207382-001	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207382-002	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207382-003	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207382-004	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207382-001	AB1	1	`9b2671bbb829…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	f72774dd-c7eb-41f9-9837-02baf77cc523	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207382 application number: ANDA207382 ndc (product): 68382-769 ndc (product): 68382-863 ndc (product): 68382-864
Topiramate	TOPIRAMATE	Zydus Lifesciences Limited	9a943af0-1c6d-43c2-830a-f303baa16124	2023-11-08		Exact identifier application applno (ANDA): 207382 application number: ANDA207382 ndc (product): 70771-1315 ndc (product): 70771-1317 ndc (product): 70771-1316

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals (US	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals (US	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals (US	ANDA	Current
70771-1315	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1315	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1315	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1315	Topiramate	Topiramate	Zydus Lifesciences Limited	ANDA	Current
70771-1316	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1316	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1316	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1316	Topiramate	Topiramate	Zydus Lifesciences Limited	ANDA	Current
70771-1317	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1317	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1317	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1317	Topiramate	Topiramate	Zydus Lifesciences Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50732	ORIG	2017-12-18