Application 215431

Type: NDA
Sponsor: AXSOME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYMBRAVO	MELOXICAM; RIZATRIPTAN BENZOATE	TABLET;ORAL	20MG;EQ 10MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N215431-001	SYMBRAVO	MELOXICAM; RIZATRIPTAN BENZOATE	20MG;EQ 10MG BASE	TABLET / ORAL		RLD, RS	2025-01-30

Orange Book patents#

Current patent rows page 1 of 2 · 96 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215431-001	10029010	2036-04-11	U-4133		2025-02-27
N215431-001	10058614	2036-04-11		Drug product	2025-02-27
N215431-001	10137131	2036-04-11	U-1719	Drug product	2025-02-27
N215431-001	10195278	2036-04-11	U-1719		2025-02-27
N215431-001	10265324	2036-04-11	U-1719		2025-02-27
N215431-001	10265399	2036-04-11	U-4509		2026-05-22
N215431-001	10265400	2036-04-11	U-4509		2026-05-22
N215431-001	10307484	2036-04-11	U-4509		2026-05-22
N215431-001	10363312	2036-04-11	U-1719		2025-02-27
N215431-001	10369224	2036-04-11	U-4134		2025-02-27
N215431-001	10369225	2036-04-11	U-4356		2026-05-22
N215431-001	10426839	2036-04-11	U-4135		2025-02-27
N215431-001	10456471	2036-04-11	U-4509		2026-05-22
N215431-001	10463736	2036-04-11		Drug product	2025-02-27
N215431-001	10471014	2036-04-11	U-1719		2025-02-27
N215431-001	10471069	2036-04-11	U-1719		2025-02-27
N215431-001	10512692	2036-04-11	U-1719		2025-02-27
N215431-001	10512693	2036-04-11	U-1719		2025-02-27
N215431-001	10517950	2036-04-11	U-1719		2025-02-27
N215431-001	10532101	2036-04-11	U-1719		2025-02-27
N215431-001	10537642	2036-04-11	U-1719		2025-02-27
N215431-001	10561664	2036-04-11	U-1719		2025-02-27
N215431-001	10583144	2036-04-11	U-1719		2025-02-27
N215431-001	10653777	2036-04-11	U-1719		2025-02-27
N215431-001	10688102	2036-04-11	U-1719		2025-02-27
N215431-001	10688185	2036-04-11	U-1719		2025-02-27
N215431-001	10695429	2036-04-11	U-1719		2025-02-27
N215431-001	10695430	2036-04-11	U-1719		2025-02-27
N215431-001	10702535	2036-04-11	U-4136		2025-02-27
N215431-001	10702602	2036-04-11	U-1719		2025-02-27
N215431-001	10722583	2036-04-11	U-1719		2025-02-27
N215431-001	10729696	2036-04-11	U-1719		2025-02-27
N215431-001	10729697	2036-04-11	U-1719		2025-02-27
N215431-001	10729773	2036-04-11	U-1719		2025-02-27
N215431-001	10758617	2036-04-11	U-1719		2025-02-27
N215431-001	10758618	2036-04-11	U-1719		2025-02-27
N215431-001	10780165	2036-04-11	U-1719		2025-02-27
N215431-001	10780166	2036-04-11	U-1719		2025-02-27
N215431-001	10799588	2036-04-11	U-1719		2025-02-27
N215431-001	10821181	2036-04-11	U-1719		2025-02-27
N215431-001	10821182	2036-04-11	U-1719		2025-02-27
N215431-001	10894053	2036-04-11	U-1719		2025-02-27
N215431-001	10905693	2036-04-11	U-1719		2025-02-27
N215431-001	10918722	2036-04-11	U-1719		2025-02-27
N215431-001	10933136	2036-04-11	U-1719		2025-02-27
N215431-001	10933137	2036-04-11	U-1719		2025-02-27
N215431-001	10940153	2036-04-11	U-1719		2025-02-27
N215431-001	10987358	2036-04-11	U-1719		2025-02-27
N215431-001	11013805	2036-04-11	U-1719		2025-02-27
N215431-001	11013806	2036-04-11	U-1719		2025-02-27
N215431-001	11020483	2036-04-11	U-1719		2025-02-27
N215431-001	11045549	2036-04-11	U-1719		2025-02-27
N215431-001	11135295	2036-04-11	U-1719		2025-02-27
N215431-001	11207328	2036-04-11	U-1719		2025-02-27
N215431-001	11219626	2036-04-11	U-1719		2025-02-27
N215431-001	11266657	2036-04-11	U-1719		2026-05-22
N215431-001	11285213	2036-04-11	U-1719		2025-02-27
N215431-001	11331323	2036-04-11	U-1719		2025-02-27
N215431-001	11369684	2036-04-11	U-1719		2025-02-27
N215431-001	11426414	2036-04-11	U-1719		2025-02-27
N215431-001	11433078	2036-04-11	U-1719		2026-05-22
N215431-001	11433079	2036-04-11	U-1719		2026-05-22
N215431-001	11471464	2036-04-11	U-1719		2025-02-27
N215431-001	11471465	2036-04-11	U-1719		2025-02-27
N215431-001	11504429	2036-04-11	U-1719		2025-02-27
N215431-001	11510927	2036-04-11	U-1719		2025-02-27
N215431-001	11571428	2036-04-11	U-1719		2025-02-27
N215431-001	11602563	2036-04-11	U-1719		2025-02-27
N215431-001	11607456	2036-04-11	U-1719		2025-02-27
N215431-001	11617755	2036-04-11	U-1719		2025-02-27
N215431-001	11617756	2036-04-11	U-1719		2025-02-27
N215431-001	11617791	2036-04-11	U-1719		2025-02-27
N215431-001	11628173	2036-04-11	U-1719		2025-02-27
N215431-001	11712441	2036-04-11	U-1719		2025-02-27
N215431-001	11738085	2036-04-11	U-1719		2025-02-27
N215431-001	11759522	2036-04-11	U-1719		2025-02-27
N215431-001	11801250	2036-04-11	U-1719		2025-02-27
N215431-001	11806354	2036-04-11	U-1719		2025-02-27
N215431-001	11826370	2036-04-11	U-1719		2025-02-27
N215431-001	11865117	2036-04-11	U-1719		2025-02-27

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215431-001	NP	2028-01-30

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
2026-10-15 13:18:30	2026-09	N215431-001	SYMBRAVO	20MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2025-01-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215431-001	SYMBRAVO	20MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2025-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215431-001	SYMBRAVO	20MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2025-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215431-001	SYMBRAVO	20MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2025-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215431-001	SYMBRAVO	20MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2025-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215431-001	SYMBRAVO	20MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2025-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215431-001	SYMBRAVO	20MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2025-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215431-001	SYMBRAVO	20MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2025-01-30	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215431-001	SYMBRAVO	20MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2025-01-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 2 of 18 · 683 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215431-001	10821182	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	10894053	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	10905693	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	10918722	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	10933136	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	10933137	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	10940153	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	10987358	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11013805	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11013806	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11020483	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11045549	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11135295	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11207328	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11219626	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11266657	2036-04-11	U-1719	2026-05-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11285213	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11331323	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11369684	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11426414	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11433078	2036-04-11	U-1719	2026-05-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11433079	2036-04-11	U-1719	2026-05-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11471464	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11471465	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11504429	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11510927	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11571428	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11602563	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11607456	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11617755	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11617756	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11617791	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11628173	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11712441	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11738085	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11759522	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11801250	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11806354	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11826370	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215431-001	11865117	2036-04-11	U-1719	2025-02-27	`c2088c7a36db…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N215431-001	NP	2028-01-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215431-001	NP	2028-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215431-001	NP	2028-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215431-001	NP	2028-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215431-001	NP	2028-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215431-001	NP	2028-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215431-001	NP	2028-01-30	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215431-001	NP	2028-01-30	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83236	ORIG	2025-08-29
81099	ORIG	2025-02-27
80988	ORIG	2025-02-05
80983	ORIG	2025-02-05