Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SPIRONOLACTONE | SPIRONOLACTONE | 25MG | 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 |
---|---|---|---|---|---|---|---|
07/10/1980 | 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 |
---|---|---|---|---|---|
05/19/2015 | SUPPL-69 | Labeling-Package Insert |
Label is not available on this site. |
||
09/22/2014 | SUPPL-67 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2014 | SUPPL-66 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/22/2014 | SUPPL-65 | Labeling-Package Insert |
Label is not available on this site. |
||
02/25/2009 | SUPPL-62 | Labeling |
Label is not available on this site. |
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12/16/2002 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/17/2002 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/09/2001 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/13/2000 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
01/11/2001 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/17/2000 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/05/1999 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/10/1998 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
10/21/1997 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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05/16/1996 | SUPPL-43 | Labeling |
Label is not available on this site. |
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12/01/1995 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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01/24/1995 | SUPPL-41 | Labeling |
Label is not available on this site. |
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06/20/1994 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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04/22/1991 | SUPPL-39 | Labeling |
Label is not available on this site. |
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04/20/1988 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/20/1988 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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01/30/1987 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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01/30/1987 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/30/1987 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/26/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/29/1986 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/29/1986 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/15/1986 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/02/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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08/05/1983 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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08/05/1983 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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01/27/1983 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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01/27/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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04/26/1982 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |