Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018197
Company: BASF
Company: BASF
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBU | IBUPROFEN | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| RUFEN | 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 |
|---|---|---|---|---|---|---|---|
| 05/21/1981 | 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 |
|---|---|---|---|---|---|
| 03/06/1995 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 01/05/1995 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 10/09/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 10/25/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 01/19/1989 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 10/28/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 01/17/1989 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 07/01/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/17/1986 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/17/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/17/1986 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/17/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/01/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |