FDA.reportPublic FDA data

Application 215431

Type
NDA
Sponsor
AXSOME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYMBRAVOMELOXICAM; RIZATRIPTAN BENZOATETABLET;ORAL20MG;EQ 10MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215431-001SYMBRAVOMELOXICAM; RIZATRIPTAN BENZOATE20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215431-001100290102036-04-11U-41332025-02-27
N215431-001100586142036-04-11Drug product2025-02-27
N215431-001101371312036-04-11U-1719Drug product2025-02-27
N215431-001101952782036-04-11U-17192025-02-27
N215431-001102653242036-04-11U-17192025-02-27
N215431-001102653992036-04-11U-45092026-05-22
N215431-001102654002036-04-11U-45092026-05-22
N215431-001103074842036-04-11U-45092026-05-22
N215431-001103633122036-04-11U-17192025-02-27
N215431-001103692242036-04-11U-41342025-02-27
N215431-001103692252036-04-11U-43562026-05-22
N215431-001104268392036-04-11U-41352025-02-27
N215431-001104564712036-04-11U-45092026-05-22
N215431-001104637362036-04-11Drug product2025-02-27
N215431-001104710142036-04-11U-17192025-02-27
N215431-001104710692036-04-11U-17192025-02-27
N215431-001105126922036-04-11U-17192025-02-27
N215431-001105126932036-04-11U-17192025-02-27
N215431-001105179502036-04-11U-17192025-02-27
N215431-001105321012036-04-11U-17192025-02-27
N215431-001105376422036-04-11U-17192025-02-27
N215431-001105616642036-04-11U-17192025-02-27
N215431-001105831442036-04-11U-17192025-02-27
N215431-001106537772036-04-11U-17192025-02-27
N215431-001106881022036-04-11U-17192025-02-27
N215431-001106881852036-04-11U-17192025-02-27
N215431-001106954292036-04-11U-17192025-02-27
N215431-001106954302036-04-11U-17192025-02-27
N215431-001107025352036-04-11U-41362025-02-27
N215431-001107026022036-04-11U-17192025-02-27
N215431-001107225832036-04-11U-17192025-02-27
N215431-001107296962036-04-11U-17192025-02-27
N215431-001107296972036-04-11U-17192025-02-27
N215431-001107297732036-04-11U-17192025-02-27
N215431-001107586172036-04-11U-17192025-02-27
N215431-001107586182036-04-11U-17192025-02-27
N215431-001107801652036-04-11U-17192025-02-27
N215431-001107801662036-04-11U-17192025-02-27
N215431-001107995882036-04-11U-17192025-02-27
N215431-001108211812036-04-11U-17192025-02-27
N215431-001108211822036-04-11U-17192025-02-27
N215431-001108940532036-04-11U-17192025-02-27
N215431-001109056932036-04-11U-17192025-02-27
N215431-001109187222036-04-11U-17192025-02-27
N215431-001109331362036-04-11U-17192025-02-27
N215431-001109331372036-04-11U-17192025-02-27
N215431-001109401532036-04-11U-17192025-02-27
N215431-001109873582036-04-11U-17192025-02-27
N215431-001110138052036-04-11U-17192025-02-27
N215431-001110138062036-04-11U-17192025-02-27
N215431-001110204832036-04-11U-17192025-02-27
N215431-001110455492036-04-11U-17192025-02-27
N215431-001111352952036-04-11U-17192025-02-27
N215431-001112073282036-04-11U-17192025-02-27
N215431-001112196262036-04-11U-17192025-02-27
N215431-001112666572036-04-11U-17192026-05-22
N215431-001112852132036-04-11U-17192025-02-27
N215431-001113313232036-04-11U-17192025-02-27
N215431-001113696842036-04-11U-17192025-02-27
N215431-001114264142036-04-11U-17192025-02-27
N215431-001114330782036-04-11U-17192026-05-22
N215431-001114330792036-04-11U-17192026-05-22
N215431-001114714642036-04-11U-17192025-02-27
N215431-001114714652036-04-11U-17192025-02-27
N215431-001115044292036-04-11U-17192025-02-27
N215431-001115109272036-04-11U-17192025-02-27
N215431-001115714282036-04-11U-17192025-02-27
N215431-001116025632036-04-11U-17192025-02-27
N215431-001116074562036-04-11U-17192025-02-27
N215431-001116177552036-04-11U-17192025-02-27
N215431-001116177562036-04-11U-17192025-02-27
N215431-001116177912036-04-11U-17192025-02-27
N215431-001116281732036-04-11U-17192025-02-27
N215431-001117124412036-04-11U-17192025-02-27
N215431-001117380852036-04-11U-17192025-02-27
N215431-001117595222036-04-11U-17192025-02-27
N215431-001118012502036-04-11U-17192025-02-27
N215431-001118063542036-04-11U-17192025-02-27
N215431-001118263702036-04-11U-17192025-02-27
N215431-001118651172036-04-11U-17192025-02-27

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215431-001NP2028-01-30

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-3084e616aacf4f…
2026-08-18 06:07:402026-07N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 15 · 587 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N215431-001100290102036-04-11U-41332025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001100586142036-04-11Drug product2025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001101371312036-04-11U-1719Drug product2025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001101952782036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001102653242036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001102653992036-04-11U-45092026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001102654002036-04-11U-45092026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001103074842036-04-11U-45092026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001103633122036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001103692242036-04-11U-41342025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001103692252036-04-11U-43562026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104268392036-04-11U-41352025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104564712036-04-11U-45092026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104637362036-04-11Drug product2025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104710142036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104710692036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105126922036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105126932036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105179502036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105321012036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105376422036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105616642036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105831442036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106537772036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106881022036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106881852036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106954292036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106954302036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107025352036-04-11U-41362025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107026022036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107225832036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107296962036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107296972036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107297732036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107586172036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107586182036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107801652036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107801662036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107995882036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001108211812036-04-11U-17192025-02-2784e616aacf4f…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N215431-001NP2028-01-3084e616aacf4f…
2026-08-18 06:07:402026-07N215431-001NP2028-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215431-001NP2028-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215431-001NP2028-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N215431-001NP2028-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215431-001NP2028-01-30fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215431-001NP2028-01-30a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SYMBRAVOMELOXICAM, RIZATRIPTANAxsome Therapeutics, Inc.dcf1ecd1-08a0-8e47-e053-2a95a90abdc72025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 215431
application number: NDA215431

Reported adverse events (FAERS/openFDA)#

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

Documents#

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