Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070099
Company: BASF
Company: BASF
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBU | IBUPROFEN | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/29/1985 | 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 |
|---|---|---|---|---|---|
| 02/15/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/11/1995 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1992 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/17/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/03/1992 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1992 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1991 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/16/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/10/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 10/07/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/08/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/27/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/17/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |