Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074473
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLMETIN SODIUM | TOLMETIN SODIUM | EQ 600MG BASE | TABLET;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/30/1994 | 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 |
|---|---|---|---|---|---|
| 11/21/2024 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2023 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/25/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/22/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/02/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |