Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040910
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE AND ASPIRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | TABLET;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 07/16/2020 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/07/2025 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-3 | REMS-Modified |
Label is not available on this site. |