Drugs@FDA: FDA-Approved Drugs
Company: AMNEAL PHARMS
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 |
---|---|---|---|---|---|---|---|
07/02/2010 | 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 |
---|---|---|---|---|---|
06/28/2023 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
02/22/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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08/05/2019 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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12/02/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
12/02/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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12/02/2015 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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12/02/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/02/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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11/28/2011 | SUPPL-2 | Labeling-Package Insert |
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 |