Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073517
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOPROFEN | KETOPROFEN | 75MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/22/1992 | 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-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2006 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/08/2006 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/14/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/26/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/14/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |