Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012151
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDACTONE SPIRONOLACTONE 50MG TABLET;ORAL Prescription AB Yes No
ALDACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription AB Yes No
ALDACTONE SPIRONOLACTONE 100MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/21/1960 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2016 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

05/01/2015 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

10/22/2014 SUPPL-72 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012151s072lbl.pdf
06/12/2013 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012151s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012151Orig1s071ltr.pdf
09/17/2012 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012151s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012151Orig1s068ltr.pdf
09/22/2011 SUPPL-67 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012151s067ltr.pdf
11/25/2008 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/012151s062ltr.pdf
11/26/2002 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1999 SUPPL-60 Labeling

Label is not available on this site.

01/13/1999 SUPPL-59 Labeling

Label is not available on this site.

05/14/1996 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

05/31/1995 SUPPL-57 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1997 SUPPL-56 Labeling

Label is not available on this site.

05/07/1992 SUPPL-55 Labeling

Label is not available on this site.

01/23/1990 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

03/15/1990 SUPPL-53 Labeling

Label is not available on this site.

10/30/1989 SUPPL-52 Labeling

Label is not available on this site.

11/09/1988 SUPPL-50 Labeling

Label is not available on this site.

06/15/1987 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1987 SUPPL-48 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/13/1986 SUPPL-47 Labeling

Label is not available on this site.

09/26/1985 SUPPL-46 Labeling

Label is not available on this site.

08/15/1985 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

11/05/1984 SUPPL-44 Labeling

Label is not available on this site.

03/22/1984 SUPPL-43 Labeling

Label is not available on this site.

12/20/1983 SUPPL-42 Labeling

Label is not available on this site.

07/29/1983 SUPPL-41 Labeling

Label is not available on this site.

04/07/1983 SUPPL-40 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/30/1982 SUPPL-38 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/03/1982 SUPPL-37 Labeling

Label is not available on this site.

11/29/1983 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/30/1997 SUPPL-35 Labeling

Label is not available on this site.

06/22/1981 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/29/1983 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/04/1981 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/30/1981 SUPPL-30 Efficacy

Label is not available on this site.

11/10/1976 SUPPL-22 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/22/2014 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012151s072lbl.pdf
06/12/2013 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012151s071lbl.pdf
09/17/2012 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012151s068lbl.pdf
11/25/2008 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf

ALDACTONE

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 202187 ORION CORP ORION
SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET;ORAL Prescription No AB 089424 SUN PHARM INDUSTRIES
SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET;ORAL Prescription No AB 040750 VINTAGE

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 203253 JUBILANT GENERICS
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription No AB 040424 MYLAN
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription No AB 202187 ORION CORP ORION
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription No AB 086809 SANDOZ
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription No AB 089424 SUN PHARM INDUSTRIES
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription No AB 040750 VINTAGE

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 202187 ORION CORP ORION
SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET;ORAL Prescription No AB 089424 SUN PHARM INDUSTRIES
SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET;ORAL Prescription No AB 040750 VINTAGE

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