Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/23/1986 | 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 |
|---|---|---|---|---|---|
| 03/08/2021 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/25/2019 | SUPPL-58 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2015 | SUPPL-55 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-53 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/15/2011 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/23/2012 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 04/30/2009 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 06/05/2002 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/11/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1999 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/11/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1999 | SUPPL-18 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 12/07/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/16/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/30/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/08/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/29/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/29/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
SPIRONOLACTONE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALDACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 012151 | PFIZER |
| SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | No | AB | 203512 | ACCORD HLTHCARE |
| SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | No | AB | 091426 | AMNEAL PHARMS |
| SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | No | AB | 202187 | AUROBINDO PHARMA |
| SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | No | AB | 203253 | JUBILANT GENERICS |
| SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | No | AB | 040424 | MYLAN |
| SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | No | AB | 040750 | OXFORD PHARMS |
| SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | No | AB | 089424 | SUN PHARM INDUSTRIES |
| SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | No | AB | 205936 | ZYDUS PHARMS |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALDACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 012151 | PFIZER |
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | No | AB | 203512 | ACCORD HLTHCARE |
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | No | AB | 091426 | AMNEAL PHARMS |
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | No | AB | 202187 | AUROBINDO PHARMA |
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | No | AB | 203253 | JUBILANT GENERICS |
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | No | AB | 040424 | MYLAN |
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | No | AB | 040750 | OXFORD PHARMS |
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | No | AB | 089424 | SUN PHARM INDUSTRIES |
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | No | AB | 205936 | ZYDUS PHARMS |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALDACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 012151 | PFIZER |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | No | AB | 203512 | ACCORD HLTHCARE |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | No | AB | 091426 | AMNEAL PHARMS |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | No | AB | 202187 | AUROBINDO PHARMA |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | No | AB | 203253 | JUBILANT GENERICS |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | No | AB | 040424 | MYLAN |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | No | AB | 040750 | OXFORD PHARMS |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | No | AB | 089424 | SUN PHARM INDUSTRIES |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | No | AB | 205936 | ZYDUS PHARMS |