Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORELCO | PROBUCOL | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| LORELCO | PROBUCOL | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/01/1977 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/26/1991 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/09/1989 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/05/1989 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/05/1989 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/06/1988 | SUPPL-41 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 07/06/1988 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 01/22/1988 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/31/1988 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/25/1986 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 08/02/1984 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/12/1984 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 05/01/1984 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/18/1983 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/07/1983 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 12/02/1981 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1981 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/23/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/13/1978 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 04/12/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/12/1979 | SUPPL-1 | Labeling |
Label is not available on this site. |