Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077968
Company: IMPAX LABS
Company: IMPAX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPRAZOLAM | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 05/24/2007 | ORIG-1 | Approval |
Label is not available on this site. |