Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073308
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLMETIN SODIUM | TOLMETIN SODIUM | EQ 400MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/24/1992 | 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. |
||
| 04/28/2021 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2016 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/23/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/2000 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/03/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/26/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |