Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LASIX | FUROSEMIDE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
03/20/1968 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
06/24/1996 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
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08/04/1995 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/06/1996 | SUPPL-56 | Labeling |
Label is not available on this site. |
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04/03/1995 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/01/1995 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1995 | SUPPL-53 | Labeling |
Label is not available on this site. |
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07/09/1993 | SUPPL-52 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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09/02/1993 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/09/1993 | SUPPL-50 | Labeling |
Label is not available on this site. |
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07/07/1993 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1995 | SUPPL-48 | Labeling |
Label is not available on this site. |
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11/13/1992 | SUPPL-47 | Labeling |
Label is not available on this site. |
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01/15/1992 | SUPPL-46 | Labeling |
Label is not available on this site. |
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09/14/1990 | SUPPL-45 | Labeling |
Label is not available on this site. |
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01/05/1990 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/15/1990 | SUPPL-43 | Labeling |
Label is not available on this site. |
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08/10/1990 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/25/1988 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/22/1987 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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01/22/1986 | SUPPL-39 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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10/01/1984 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/07/1984 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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10/22/1982 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/14/1983 | SUPPL-35 | Labeling |
Label is not available on this site. |
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06/04/1982 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/02/1986 | SUPPL-33 | Labeling |
Label is not available on this site. |
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08/28/1981 | SUPPL-32 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-31 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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02/05/1981 | SUPPL-30 | Efficacy |
Label is not available on this site. |
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03/05/1981 | SUPPL-29 | Labeling |
Label is not available on this site. |
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06/25/1979 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/02/1979 | SUPPL-27 | Labeling |
Label is not available on this site. |
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11/12/1979 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/22/1979 | SUPPL-25 | Labeling |
Label is not available on this site. |
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02/22/1979 | SUPPL-24 | Labeling |
Label is not available on this site. |
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04/14/1978 | SUPPL-23 | Labeling |
Label is not available on this site. |
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04/14/1978 | SUPPL-22 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
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08/21/1979 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/29/1976 | SUPPL-18 | Labeling |
Label is not available on this site. |
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09/29/1975 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
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03/20/1975 | SUPPL-2 | Unspecified |
Label is not available on this site. |