Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076446
Company: IMPAX PHARMS
Company: IMPAX PHARMS
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/23/2003 | ORIG-1 | Tentative Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76446 AP_ltr.pdf |