Application 214679

Type: NDA
Sponsor: AZURITY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPRONTIA	TOPIRAMATE	SOLUTION; ORAL	15MG	No	No
002	EPRONTIA	TOPIRAMATE	SOLUTION; ORAL	25MG	No	No
003	EPRONTIA	TOPIRAMATE	SOLUTION; ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214679-001	EPRONTIA	TOPIRAMATE	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N214679-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214679-001	11433046	2040-08-21	U-3413		2022-09-13
N214679-001	11433046	2040-08-21	U-3414		2022-09-13
N214679-001	11433046	2040-08-21	U-3415		2022-09-13
N214679-001	11633374	2040-08-21		Drug product	2023-04-27
N214679-001	11826343	2040-08-21		Drug product	2023-12-11
N214679-001	11911362	2040-08-21	U-3413	Drug product	2024-03-12
N214679-001	11911362	2040-08-21	U-3414	Drug product	2024-03-12
N214679-001	11911362	2040-08-21	U-3415	Drug product	2024-03-12
N214679-001	12290503	2040-08-21	U-3413	Drug product	2025-05-16
N214679-001	12290503	2040-08-21	U-3414	Drug product	2025-05-16
N214679-001	12290503	2040-08-21	U-3415	Drug product	2025-05-16

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL		RLD, RS	2021-11-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214679-001	EPRONTIA	25MG/ML	SOLUTION / ORAL	AB	RLD, RS	2021-11-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214679-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214679-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214679-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214679-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214679-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214679-001	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214679-001	AB	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214679-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 174 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214679-001	11433046	2040-08-21	U-3413		2022-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	11433046	2040-08-21	U-3414		2022-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	11433046	2040-08-21	U-3415		2022-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	11633374	2040-08-21		Drug product	2023-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	11826343	2040-08-21		Drug product	2023-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	11911362	2040-08-21	U-3413	Drug product	2024-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	11911362	2040-08-21	U-3414	Drug product	2024-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	11911362	2040-08-21	U-3415	Drug product	2024-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	12290503	2040-08-21	U-3413	Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	12290503	2040-08-21	U-3415	Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214679-001	12290503	2040-08-21	U-3414	Drug product	2025-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	11433046	2040-08-21	U-3413		2022-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	11433046	2040-08-21	U-3414		2022-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	11433046	2040-08-21	U-3415		2022-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	11633374	2040-08-21		Drug product	2023-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	11826343	2040-08-21		Drug product	2023-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	11911362	2040-08-21	U-3413	Drug product	2024-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	11911362	2040-08-21	U-3414	Drug product	2024-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	11911362	2040-08-21	U-3415	Drug product	2024-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	12290503	2040-08-21	U-3413	Drug product	2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	12290503	2040-08-21	U-3415	Drug product	2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214679-001	12290503	2040-08-21	U-3414	Drug product	2025-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214679-001	11433046	2040-08-21	U-3413		2022-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	11433046	2040-08-21	U-3414		2022-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	11433046	2040-08-21	U-3415		2022-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	11633374	2040-08-21		Drug product	2023-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	11826343	2040-08-21		Drug product	2023-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	11911362	2040-08-21	U-3413	Drug product	2024-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	11911362	2040-08-21	U-3414	Drug product	2024-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	11911362	2040-08-21	U-3415	Drug product	2024-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	12290503	2040-08-21	U-3413	Drug product	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	12290503	2040-08-21	U-3415	Drug product	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214679-001	12290503	2040-08-21	U-3414	Drug product	2025-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214679-001	11433046	2040-08-21	U-3413		2022-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214679-001	11433046	2040-08-21	U-3414		2022-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214679-001	11433046	2040-08-21	U-3415		2022-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214679-001	11633374	2040-08-21		Drug product	2023-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214679-001	11826343	2040-08-21		Drug product	2023-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214679-001	11911362	2040-08-21	U-3413	Drug product	2024-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214679-001	11911362	2040-08-21	U-3414	Drug product	2024-03-12	`fd3edfee7708…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eprontia	TOPIRAMATE	Azurity Pharmaceuticals, Inc.	e2a4df59-fead-4a01-9021-9eda02c48010	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214679 application number: NDA214679 ndc (product): 52652-9001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52652-9001	Eprontia	Topiramate	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-9001	Eprontia	Topiramate	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-9001	Eprontia	Topiramate	Azurity Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85306	SUPPL	2026-03-09
85305	SUPPL	2026-03-09
85355	SUPPL	2026-03-06
81583	SUPPL	2025-03-17
81566	SUPPL	2025-03-14
78545	SUPPL	2024-05-22
78544	SUPPL	2024-05-22
78519	SUPPL	2024-05-20
72487	SUPPL	2022-10-28
72484	SUPPL	2022-10-27
71716	ORIG	2022-08-04
69289	ORIG	2021-11-10
69275	ORIG	2021-11-08