Drugs@FDA: FDA-Approved Drugs
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORUDIS | KETOPROFEN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| ORUDIS | KETOPROFEN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| ORUDIS | KETOPROFEN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/09/1986 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018754Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/18/2006 | SUPPL-27 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018754s027_019816s010ltr.pdf |
| 08/18/2003 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18754slr026ltr.pdf |
| 08/05/1997 | SUPPL-25 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-754S025.pdf |
| 02/08/1995 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/17/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1994 | SUPPL-18 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/26/1988 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/05/1989 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/16/1990 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/11/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/05/1990 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/05/1989 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/23/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/10/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/17/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |