Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087265
Company: MUTUAL PHARM
Company: MUTUAL PHARM
| 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 |
|---|---|---|---|---|---|---|---|
| 01/28/1981 | 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-29 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1993 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/16/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/14/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/03/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |