Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070745
Company: BASF
Company: BASF
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBU | IBUPROFEN | 800MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/23/1986 | 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 |
|---|---|---|---|---|---|
| 02/27/1995 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/15/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/11/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/06/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/27/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/08/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/10/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/27/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/01/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/03/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |