Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 220326
Company: APPCO PHARMA LLC
Company: APPCO PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VILOXAZINE HYDROCHLORIDE | VILOXAZINE HYDROCHLORIDE | 100MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| VILOXAZINE HYDROCHLORIDE | VILOXAZINE HYDROCHLORIDE | 200MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| VILOXAZINE HYDROCHLORIDE | VILOXAZINE HYDROCHLORIDE | 150MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 04/28/2026 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |