Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
| 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 |
|---|---|---|---|---|---|---|---|
| 07/02/1987 | 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 |
|---|---|---|---|---|---|
| 05/17/2023 | SUPPL-55 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/17/2023 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/17/2023 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/01/2019 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2015 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2011 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2011 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/2001 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/10/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 02/01/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 07/28/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/05/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/15/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/15/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1991 | SUPPL-2 | Labeling |
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 |