Application 215239

Type: NDA
Sponsor: CATALYST PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AGAMREE	VAMOROLONE	SUSPENSION;ORAL	40MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N215239-001	AGAMREE	VAMOROLONE	40MG/ML	SUSPENSION / ORAL		RLD, RS	2023-10-26

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215239-001	10857161	2029-05-28	U-3747	Drug product	2023-11-21
N215239-001	11833159	2029-05-28		Drug product	2023-12-18
N215239-001	8334279	2029-05-28	U-3747		2023-11-21
N215239-001	11690853	2033-03-07	U-3747		2023-11-21
N215239-001	11471471	2040-03-17	U-3747		2023-11-21
N215239-001	12201639	2040-03-17	U-3747	Drug substance, Drug product	2025-02-14
N215239-001	11382922	2040-07-16		Drug substance, Drug product	2023-11-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215239-001	NCE	2028-10-26
N215239-001	ODE-450	2030-10-26

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215239-001	AGAMREE	40MG/ML	SUSPENSION / ORAL	RLD, RS	2023-10-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215239-001	10857161	2029-05-28	U-3747	Drug product	2023-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215239-001	11833159	2029-05-28		Drug product	2023-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215239-001	8334279	2029-05-28	U-3747		2023-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215239-001	11690853	2033-03-07	U-3747		2023-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215239-001	11471471	2040-03-17	U-3747		2023-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215239-001	12201639	2040-03-17	U-3747	Drug substance, Drug product	2025-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215239-001	11382922	2040-07-16		Drug substance, Drug product	2023-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215239-001	10857161	2029-05-28	U-3747	Drug product	2023-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215239-001	11833159	2029-05-28		Drug product	2023-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215239-001	8334279	2029-05-28	U-3747		2023-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215239-001	11690853	2033-03-07	U-3747		2023-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215239-001	11471471	2040-03-17	U-3747		2023-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215239-001	12201639	2040-03-17	U-3747	Drug substance, Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215239-001	11382922	2040-07-16		Drug substance, Drug product	2023-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	10857161	2029-05-28	U-3747	Drug product	2023-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	11833159	2029-05-28		Drug product	2023-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	8334279	2029-05-28	U-3747		2023-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	11690853	2033-03-07	U-3747		2023-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	11471471	2040-03-17	U-3747		2023-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	12201639	2040-03-17	U-3747	Drug substance, Drug product	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	11382922	2040-07-16		Drug substance, Drug product	2023-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215239-001	10857161	2029-05-28	U-3747	Drug product	2023-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215239-001	11833159	2029-05-28		Drug product	2023-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215239-001	8334279	2029-05-28	U-3747		2023-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215239-001	11690853	2033-03-07	U-3747		2023-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215239-001	11471471	2040-03-17	U-3747		2023-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215239-001	12201639	2040-03-17	U-3747	Drug substance, Drug product	2025-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215239-001	11382922	2040-07-16		Drug substance, Drug product	2023-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	10857161	2029-05-28	U-3747	Drug product	2023-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	11833159	2029-05-28		Drug product	2023-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	8334279	2029-05-28	U-3747		2023-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	11690853	2033-03-07	U-3747		2023-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	11471471	2040-03-17	U-3747		2023-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	12201639	2040-03-17	U-3747	Drug substance, Drug product	2025-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	11382922	2040-07-16		Drug substance, Drug product	2023-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215239-001	10857161	2029-05-28	U-3747	Drug product	2023-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215239-001	11833159	2029-05-28		Drug product	2023-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215239-001	8334279	2029-05-28	U-3747		2023-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215239-001	11690853	2033-03-07	U-3747		2023-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215239-001	11471471	2040-03-17	U-3747		2023-11-21	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215239-001	NCE	2028-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215239-001	ODE-450	2030-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215239-001	NCE	2028-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215239-001	ODE-450	2030-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	NCE	2028-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215239-001	ODE-450	2030-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215239-001	NCE	2028-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215239-001	ODE-450	2030-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	NCE	2028-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215239-001	ODE-450	2030-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215239-001	NCE	2028-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215239-001	ODE-450	2030-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215239-001	NCE	2028-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215239-001	ODE-450	2030-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215239-001	NCE	2028-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215239-001	ODE-450	2030-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215239-001	NCE	2028-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215239-001	ODE-450	2030-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215239-001	NCE	2028-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215239-001	ODE-450	2030-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215239-001	NCE	2028-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215239-001	ODE-450	2030-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215239-001	NCE	2028-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215239-001	ODE-450	2030-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215239-001	NCE	2028-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215239-001	ODE-450	2030-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215239-001	NCE	2028-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215239-001	ODE-450	2030-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215239-001	NCE	2028-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215239-001	ODE-450	2030-10-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215239-001	NCE	2028-10-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215239-001	ODE-450	2030-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215239-001	NCE	2028-10-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215239-001	ODE-450	2030-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215239-001	NCE	2028-10-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215239-001	ODE-450	2030-10-26	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215239-001	NCE	2028-10-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215239-001	ODE-450	2030-10-26	`a50c72e98297…`

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
AGAMREE	VAMOROLONE	Catalyst Pharmaceuticals, Inc.	fb376f09-cf9c-42b5-b4dd-02d5bcd73211	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215239 application number: NDA215239

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78731	SUPPL	2024-07-02
78665	SUPPL	2024-06-06
76515	ORIG	2023-11-07
75965	ORIG	2023-10-27
75950	ORIG	2023-10-26