Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021437
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INSPRA EPLERENONE 25MG TABLET;ORAL Prescription AB Yes No
INSPRA EPLERENONE 50MG TABLET;ORAL Prescription AB Yes Yes
INSPRA EPLERENONE 100MG TABLET;ORAL Discontinued None 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
09/27/2002 ORIG-1 Approval Type 1 - New Molecular Entity UNKNOWN Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21437lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21437ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-437_Inspra.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/30/2018 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021437s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021437Orig1s015ltr.pdf
05/04/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021437s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021437Orig1s013ltr.pdf
07/26/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/16/2013 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021437s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021437Orig1s011ltr.pdf
04/15/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/22/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009_2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437s009ltr.pdf
05/07/2008 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021437s006ltr.pdf
01/31/2008 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021437s005ltr.pdf
10/07/2003 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21437se1-002_inspra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21437se1-002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-437s002_Inspra.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/30/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021437s015lbl.pdf
05/04/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021437s013lbl.pdf
05/16/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021437s011lbl.pdf
06/22/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009_2lbl.pdf
06/22/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009lbl.pdf
05/07/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s006lbl.pdf
01/31/2008 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s005lbl.pdf
10/07/2003 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21437se1-002_inspra_lbl.pdf
09/27/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21437lbl.pdf

INSPRA

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPLERENONE EPLERENONE 25MG TABLET;ORAL Prescription No AB 206922 ACCORD HLTHCARE
EPLERENONE EPLERENONE 25MG TABLET;ORAL Prescription No AB 078482 APOTEX
EPLERENONE EPLERENONE 25MG TABLET;ORAL Prescription No AB 208283 BRECKENRIDGE PHARM
EPLERENONE EPLERENONE 25MG TABLET;ORAL Prescription No AB 203896 MYLAN
EPLERENONE EPLERENONE 25MG TABLET;ORAL Prescription No AB 078510 SANDOZ
INSPRA EPLERENONE 25MG TABLET;ORAL Prescription Yes AB 021437 GD SEARLE LLC

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPLERENONE EPLERENONE 50MG TABLET;ORAL Prescription No AB 206922 ACCORD HLTHCARE
EPLERENONE EPLERENONE 50MG TABLET;ORAL Prescription No AB 078482 APOTEX
EPLERENONE EPLERENONE 50MG TABLET;ORAL Prescription No AB 208283 BRECKENRIDGE PHARM
EPLERENONE EPLERENONE 50MG TABLET;ORAL Prescription No AB 203896 MYLAN
EPLERENONE EPLERENONE 50MG TABLET;ORAL Prescription No AB 078510 SANDOZ
INSPRA EPLERENONE 50MG TABLET;ORAL Prescription Yes AB 021437 GD SEARLE LLC

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