Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218628
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUCAPSOL | BUSPIRONE HYDROCHLORIDE | 7.5MG | CAPSULE;ORAL | Prescription | None | No | No |
| BUCAPSOL | BUSPIRONE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | None | No | No |
| BUCAPSOL | BUSPIRONE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/13/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/17/2025 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |