Drugs@FDA: FDA-Approved Drugs
Company: OHM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | 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 |
|---|---|---|---|---|---|---|---|
| 07/15/1986 | 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 |
|---|---|---|---|---|---|
| 06/15/2010 | SUPPL-54 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/22/2008 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 10/02/2006 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 03/22/2006 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 08/16/2001 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/2001 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/2000 | SUPPL-37 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/08/1999 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 11/18/1998 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 10/06/1997 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 08/05/1994 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1993 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/02/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/21/1992 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1992 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1993 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/21/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1990 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/17/1990 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/21/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/03/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |