Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040353
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET;ORAL Prescription AB No No
SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET;ORAL Prescription AB No No
SPIRONOLACTONE SPIRONOLACTONE 25MG 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
07/29/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40353ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

11/28/2011 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

06/11/2009 SUPPL-26 Labeling

Label is not available on this site.

04/30/2009 SUPPL-25 Labeling

Label is not available on this site.

03/15/2006 SUPPL-8 Labeling

Label is not available on this site.

03/15/2006 SUPPL-7

Label is not available on this site.

11/02/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

SPIRONOLACTONE

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 GD SEARLE LLC
SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET;ORAL Prescription No AB 203512 ACCORD HLTHCARE
SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET;ORAL Prescription No AB 040353 ACTAVIS ELIZABETH
SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET;ORAL Prescription No AB 091426 AMNEAL PHARMS
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 USA INC

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 GD SEARLE LLC
SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET;ORAL Prescription No AB 203512 ACCORD HLTHCARE
SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET;ORAL Prescription No AB 040353 ACTAVIS ELIZABETH
SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET;ORAL Prescription No AB 091426 AMNEAL PHARMS
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 USA INC

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 GD SEARLE LLC
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription No AB 203512 ACCORD HLTHCARE
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription No AB 040353 ACTAVIS ELIZABETH
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription No AB 091426 AMNEAL PHARMS
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription No AB 086809 CASI PHARMS INC
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 USA INC

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