Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078491
Company: OXFORD PHARMS
Company: OXFORD PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Discontinued | None | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/25/2008 | 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 |
|---|---|---|---|---|---|
| 12/31/2019 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/12/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |