Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE | 25MG;25MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 08/03/1979 | 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 |
|---|---|---|---|---|---|
| 04/20/2023 | SUPPL-86 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/17/2023 | SUPPL-84 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2023 | SUPPL-82 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/20/2023 | SUPPL-80 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/06/2019 | SUPPL-76 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/14/2016 | SUPPL-75 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2016 | SUPPL-73 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2013 | SUPPL-68 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2002 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/1999 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 08/26/1998 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1993 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1993 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 05/30/1991 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/04/1990 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1984 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1982 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 25MG;25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALDACTAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE | 25MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 012616 | PFIZER |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE | 25MG;25MG | TABLET;ORAL | Prescription | No | AB | 086513 | MYLAN |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE | 25MG;25MG | TABLET;ORAL | Prescription | No | AB | 089534 | SUN PHARM INDUSTRIES |