Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077822
Company: MALLINCKRODT
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 80MG | TABLET, EXTENDED RELEASE; ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/24/2008 | ORIG-1 | Approval |
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