Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076270
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Discontinued | None | No | No |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/19/2003 | 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 |
|---|---|---|---|---|---|
| 12/28/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/18/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |