Application 077627

Type: ANDA
Sponsor: GLENMARK GENERICS

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	TE codes	Approval date
A077627-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A077627-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A077627-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A077627-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077627-001	AB
A077627-002	AB
A077627-003	AB
A077627-004	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077627-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077627-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077627-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077627-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-004	AB	1	`5bbf6a4d5a75…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	3f99b26b-79b9-4efb-aa2c-2868e1e126c8	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	610d4df7-703f-4070-9adc-3e57ca05a2f1	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	Unit Dose Solutions, Inc.	562f3fec-489b-4662-e063-6294a90a4ea2	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	Glenmark Pharmaceuticals Inc., USA	35312f49-decf-428d-bf5f-4215b762ed3c	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	Northwind Health Company, LLC	ae63e0e2-ceb1-4cc7-88fa-92cfa4516960	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	Proficient Rx LP	a712d050-d5de-4685-a80a-548ab080fdb7	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	Proficient Rx LP	5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8	2020-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627

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 2 of 2 · 82 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70934-733	Topiramate	Topiramate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-772	Topiramate	Topiramate	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23878	ORIG	2009-04-14