Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087267
Company: MUTUAL PHARM
Company: MUTUAL PHARM
| 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 |
|---|---|---|---|---|---|---|---|
| 04/16/1981 | 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 |
|---|---|---|---|---|---|
| 04/22/1999 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/07/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 10/30/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 09/15/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/01/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |