Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074819
Company: OXFORD PHARMS
Company: OXFORD PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| ETODOLAC | ETODOLAC | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/28/1997 | 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-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2016 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 08/08/2006 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2001 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/25/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/09/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |