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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091426
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.

08/05/2019 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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.

12/02/2015 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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.

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
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