Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE | 25MG;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 |
---|---|---|---|---|---|---|---|
11/24/1981 | 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 |
---|---|---|---|---|---|
11/18/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
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07/08/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
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10/14/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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04/22/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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08/06/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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01/28/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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08/18/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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06/21/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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06/21/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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06/21/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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07/26/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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07/26/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/04/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |