Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 218549
Company: ALPHA COGNITION
Company: ALPHA COGNITION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZUNVEYL | BENZGALANTAMINE GLUCONATE | EQ 5MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | None | Yes | Yes |
| ZUNVEYL | BENZGALANTAMINE GLUCONATE | EQ 10MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | None | Yes | No |
| ZUNVEYL | BENZGALANTAMINE GLUCONATE | EQ 15MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/26/2024 | ORIG-1 | Approval | Type 2 - New Active Ingredient and Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218549s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218549Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218549Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/26/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218549s000lbl.pdf |