Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077657
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| LORAZEPAM | LORAZEPAM | 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 |
|---|---|---|---|---|---|---|---|
| 03/16/2006 | 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 |
|---|---|---|---|---|---|
| 01/05/2026 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/26/2025 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/26/2025 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/26/2025 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |