Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012151
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALDACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ALDACTONE | SPIRONOLACTONE | 25MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ALDACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/21/1960 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/19/2022 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012151s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/012151Orig1s079ltr.pdf | |
| 07/28/2020 | SUPPL-77 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012151s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/012151Orig1s077ltr.pdf | |
| 03/06/2018 | SUPPL-75 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012151s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012151Orig1s075ltr.pdf | |
| 04/11/2016 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/2015 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/2014 | SUPPL-72 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012151s072lbl.pdf | |
| 06/12/2013 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012151s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012151Orig1s071ltr.pdf | |
| 09/17/2012 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012151s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012151Orig1s068ltr.pdf | |
| 09/22/2011 | SUPPL-67 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012151s067ltr.pdf |
| 11/25/2008 | SUPPL-62 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/012151s062ltr.pdf | |
| 11/26/2002 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1999 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 01/13/1999 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 05/14/1996 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1995 | SUPPL-57 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/1997 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 01/23/1990 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1990 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 10/30/1989 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 11/09/1988 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 06/15/1987 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-48 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/13/1986 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 08/15/1985 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1984 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 03/22/1984 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 12/20/1983 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 07/29/1983 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 04/07/1983 | SUPPL-40 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/30/1982 | SUPPL-38 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/03/1982 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 11/29/1983 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/30/1997 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 06/22/1981 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1983 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/04/1981 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/30/1981 | SUPPL-30 | Efficacy |
Label is not available on this site. |
||
| 11/10/1976 | SUPPL-22 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/19/2022 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012151s079lbl.pdf | |
| 07/28/2020 | SUPPL-77 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012151s077lbl.pdf | |
| 03/06/2018 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012151s075lbl.pdf | |
| 10/22/2014 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012151s072lbl.pdf | |
| 06/12/2013 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012151s071lbl.pdf | |
| 09/17/2012 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012151s068lbl.pdf | |
| 11/25/2008 | SUPPL-62 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf |
ALDACTONE
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; 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; 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 |