Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073519
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 |
|---|---|---|---|---|---|---|---|
| 05/29/1992 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |