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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021437
Company: UPJOHN

Products on NDA 021437

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021437

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/2012/021437s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009_2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437Orig1s009ltr.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

Labels for NDA 021437

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

Therapeutic Equivalents for NDA 021437

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	213812	ANNORA PHARMA
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	208283	BRECKENRIDGE
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	078482	CHARTWELL RX
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	214663	RISING
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	078510	SANDOZ
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	212765	SLATE RUN PHARMA
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	207842	WESTMINSTER PHARMS
INSPRA	EPLERENONE	25MG	TABLET;ORAL	Prescription	Yes	AB	021437	UPJOHN

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	213812	ANNORA PHARMA
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	208283	BRECKENRIDGE
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	078482	CHARTWELL RX
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	214663	RISING
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	078510	SANDOZ
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	212765	SLATE RUN PHARMA
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	207842	WESTMINSTER PHARMS
INSPRA	EPLERENONE	50MG	TABLET;ORAL	Prescription	Yes	AB	021437	UPJOHN

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