Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FUROSEMIDE | FUROSEMIDE | 40MG/5ML | SOLUTION;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
04/22/1987 | 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 |
---|---|---|---|---|---|
11/05/2020 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
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11/05/2020 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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05/11/2012 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
01/26/2011 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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05/04/2009 | SUPPL-27 | Labeling |
Label is not available on this site. |
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03/28/2007 | SUPPL-26 | Labeling |
Label is not available on this site. |
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05/23/2002 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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09/22/2000 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/22/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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10/08/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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08/28/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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04/21/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
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04/21/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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04/21/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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04/21/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/21/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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06/24/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
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08/28/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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12/18/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/28/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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11/07/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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11/07/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/19/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
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07/13/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |