Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220415
Company: ABBVIE INC
Company: ABBVIE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JUVMO | TAVAPADON | 0.25MG | TABLET; ORAL | Prescription | None | No | No |
| JUVMO | TAVAPADON | 1MG | TABLET; ORAL | Prescription | None | No | No |
| JUVMO | TAVAPADON | 5MG | TABLET; ORAL | Prescription | None | No | No |
| JUVMO | TAVAPADON | 10MG | TABLET; ORAL | Prescription | None | No | No |
| JUVMO | TAVAPADON | 15MG | TABLET; ORAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/25/2026 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220415Orig1s000ltr.pdf |