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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205936
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
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