Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089424
Company: SUN PHARM INDUSTRIES
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
07/23/1986 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
09/22/2015 SUPPL-55 Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-53 Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-52 Labeling-Package Insert

Label is not available on this site.

11/15/2011 SUPPL-51 Labeling-Package Insert

Label is not available on this site.

01/23/2012 SUPPL-49 Labeling

Label is not available on this site.

04/30/2009 SUPPL-48 Labeling

Label is not available on this site.

06/05/2002 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/05/2002 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2000 SUPPL-26 Labeling

Label is not available on this site.

10/02/2000 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/2000 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

08/11/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/11/1999 SUPPL-21 Labeling

Label is not available on this site.

08/11/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/11/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/11/1999 SUPPL-18 Manufacturing (CMC)-New Strength

Label is not available on this site.

12/07/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/16/1998 SUPPL-16 Labeling

Label is not available on this site.

12/05/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/13/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/13/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/26/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/12/1996 SUPPL-10 Labeling

Label is not available on this site.

06/22/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/07/1993 SUPPL-7 Labeling

Label is not available on this site.

08/16/1991 SUPPL-6 Labeling

Label is not available on this site.

04/30/1990 SUPPL-5 Labeling

Label is not available on this site.

11/08/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/23/1989 SUPPL-3 Labeling

Label is not available on this site.

04/29/1988 SUPPL-2 Labeling

Label is not available on this site.

04/29/1988 SUPPL-1 Manufacturing (CMC)

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 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 202187 AUROBINDO PHARMA LTD
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

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 202187 AUROBINDO PHARMA LTD
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 202187 AUROBINDO PHARMA LTD
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

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