Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL RX
| 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 05/09/2001 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1998 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1997 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/07/1996 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/20/1994 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/23/1990 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 12/27/1990 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 03/31/1989 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1989 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1986 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1986 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1986 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1984 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/11/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/11/1984 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1985 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1983 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/11/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1983 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1982 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |