Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086809
Company: CASI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
07/10/1980 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
05/19/2015 SUPPL-69 Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-67 Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-66 Labeling-Patient Package Insert

Label is not available on this site.

09/22/2014 SUPPL-65 Labeling-Package Insert

Label is not available on this site.

02/25/2009 SUPPL-62 Labeling

Label is not available on this site.

12/16/2002 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/2002 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/2000 SUPPL-49 Labeling

Label is not available on this site.

01/11/2001 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/2000 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

06/10/1998 SUPPL-45 Labeling

Label is not available on this site.

10/21/1997 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

05/16/1996 SUPPL-43 Labeling

Label is not available on this site.

12/01/1995 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

01/24/1995 SUPPL-41 Labeling

Label is not available on this site.

06/20/1994 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

04/22/1991 SUPPL-39 Labeling

Label is not available on this site.

04/20/1988 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

04/20/1988 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/30/1987 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/30/1987 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/30/1987 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/26/1986 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/29/1986 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/29/1986 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/15/1986 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/02/1984 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/05/1983 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/05/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/27/1983 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/27/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/26/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/24/1982 SUPPL-20 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

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