Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205936
Company: ZYDUS PHARMS
Company: ZYDUS 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 |
---|---|---|---|---|---|---|---|
07/18/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/26/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
03/02/2021 | 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 |