Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073393
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLMETIN SODIUM | TOLMETIN SODIUM | EQ 400MG BASE | CAPSULE;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 05/27/1993 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/08/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |