Drugs@FDA: FDA-Approved Drugs
Company: PERRIGO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAP-PROFEN | IBUPROFEN | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/08/1987 | 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 |
|---|---|---|---|---|---|
| 09/12/2001 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/21/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/2001 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/26/2000 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/20/2004 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1999 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 08/16/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/25/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/06/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |