Application 218549
- Type
- NDA
- Sponsor
- ALPHA COGNITION
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZUNVEYL | BENZGALANTAMINE GLUCONATE | TABLET, DELAYED RELEASE;ORAL | EQ 5MG BASE | Yes | Yes |
| 002 | ZUNVEYL | BENZGALANTAMINE GLUCONATE | TABLET, DELAYED RELEASE;ORAL | EQ 10MG BASE | Yes | No |
| 003 | ZUNVEYL | BENZGALANTAMINE GLUCONATE | TABLET, DELAYED RELEASE;ORAL | EQ 15MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N218549-001 | ZUNVEYL | BENZGALANTAMINE GLUCONATE | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | |
| N218549-002 | ZUNVEYL | BENZGALANTAMINE GLUCONATE | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | |
| N218549-003 | ZUNVEYL | BENZGALANTAMINE GLUCONATE | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N218549-001 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | |
| N218549-001 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 |
| N218549-001 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 |
| N218549-001 | 12551491 | 2045-07-23 | U-713 | 2026-02-20 | |
| N218549-002 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | |
| N218549-002 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 |
| N218549-002 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 |
| N218549-002 | 12551491 | 2045-07-23 | U-713 | 2026-02-20 | |
| N218549-003 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | |
| N218549-003 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 |
| N218549-003 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 |
| N218549-003 | 12551491 | 2045-07-23 | U-713 | 2026-02-20 |
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 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N218549-002 | ZUNVEYL | EQ 10MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N218549-003 | ZUNVEYL | EQ 15MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2024-07-26 | 79d66fd596c7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218549-001 | ZUNVEYL | EQ 5MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2024-07-26 | 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 | N218549-001 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N218549-001 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N218549-001 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N218549-001 | 12551491 | 2045-07-23 | U-713 | 2026-02-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N218549-002 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N218549-002 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N218549-002 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N218549-002 | 12551491 | 2045-07-23 | U-713 | 2026-02-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N218549-003 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N218549-003 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N218549-003 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N218549-003 | 12551491 | 2045-07-23 | U-713 | 2026-02-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N218549-001 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218549-001 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N218549-001 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N218549-001 | 12551491 | 2045-07-23 | U-713 | 2026-02-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218549-002 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218549-002 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N218549-002 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N218549-002 | 12551491 | 2045-07-23 | U-713 | 2026-02-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218549-003 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218549-003 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N218549-003 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N218549-003 | 12551491 | 2045-07-23 | U-713 | 2026-02-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-001 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-001 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-001 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-002 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-002 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-002 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-003 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-003 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218549-003 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-001 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-001 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-001 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-002 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-002 | 11795176 | 2042-01-13 | U-713 | Drug substance | 2024-08-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-002 | 12208167 | 2044-02-26 | U-713 | Drug product | 2025-02-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218549-003 | 9763953 | 2026-12-01 | U-713 | 2024-08-22 | 31067a03dcf5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.