Application 215431
- Type
- NDA
- Sponsor
- AXSOME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SYMBRAVO | MELOXICAM; RIZATRIPTAN BENZOATE | TABLET;ORAL | 20MG;EQ 10MG BASE | Yes | Yes |
Orange Book products#
| 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#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215431-001 | 11944683 | 2036-04-11 | U-1719 | 2026-05-22 | |
| N215431-001 | 12485176 | 2036-04-11 | U-4133 | 2025-12-11 | |
| N215431-001 | 12691123 | 2036-04-11 | U-1719 | 2026-08-21 | |
| N215431-001 | 9821075 | 2036-04-11 | U-1719 | Drug product | 2025-02-27 |
| N215431-001 | 12472256 | 2038-05-18 | U-4356 | 2025-12-11 | |
| N215431-001 | 12472257 | 2038-05-18 | U-4134 | 2025-12-11 | |
| N215431-001 | 12472258 | 2038-05-18 | Drug product | 2025-12-11 | |
| N215431-001 | 12616752 | 2038-05-18 | U-4510 | 2026-05-22 | |
| N215431-001 | 12685736 | 2040-05-09 | U-1719 | 2026-08-21 | |
| N215431-001 | 12128052 | 2040-05-28 | U-1719 | 2025-02-27 | |
| N215431-001 | 12551488 | 2040-05-28 | U-1719 | 2026-03-09 | |
| N215431-001 | 12551489 | 2040-05-28 | U-1719 | 2026-03-09 | |
| N215431-001 | 12370196 | 2041-12-29 | U-1719 | 2025-08-04 | |
| N215431-001 | 12611413 | 2041-12-29 | U-1719 | 2026-05-22 | |
| N215431-001 | 12005118 | 2043-01-25 | U-1719 | 2026-05-22 | |
| N215431-001 | 12544383 | 2045-03-10 | U-1719 | 2026-03-09 |
Orange Book exclusivity#
| 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10029010 | 2036-04-11 | U-4133 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10058614 | 2036-04-11 | Drug product | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10137131 | 2036-04-11 | U-1719 | Drug product | 2025-02-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10195278 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10265324 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10265399 | 2036-04-11 | U-4509 | 2026-05-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10265400 | 2036-04-11 | U-4509 | 2026-05-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10307484 | 2036-04-11 | U-4509 | 2026-05-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10363312 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10369224 | 2036-04-11 | U-4134 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10369225 | 2036-04-11 | U-4356 | 2026-05-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10426839 | 2036-04-11 | U-4135 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10456471 | 2036-04-11 | U-4509 | 2026-05-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10463736 | 2036-04-11 | Drug product | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10471014 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10471069 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10512692 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10512693 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10517950 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10532101 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10537642 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10561664 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10583144 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10653777 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10688102 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10688185 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10695429 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10695430 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10702535 | 2036-04-11 | U-4136 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10702602 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10722583 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10729696 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10729697 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10729773 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10758617 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10758618 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10780165 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10780166 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10799588 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215431-001 | 10821181 | 2036-04-11 | U-1719 | 2025-02-27 | 84e616aacf4f… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 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.