Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
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 |
---|---|---|---|---|---|---|---|
02/03/1981 | 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 |
---|---|---|---|---|---|
09/13/2000 | SUPPL-27 | Labeling |
Label is not available on this site. |
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04/03/2000 | SUPPL-26 | Labeling |
Label is not available on this site. |
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08/26/1998 | SUPPL-25 | Labeling |
Label is not available on this site. |
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02/05/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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02/25/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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06/01/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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06/01/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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06/01/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
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12/26/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
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01/31/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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11/10/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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10/17/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/10/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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09/18/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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12/02/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |