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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021985
Company: NODEN PHARMA

Other Important Information from FDA

Products on NDA 021985

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 150MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 300MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021985

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/2007	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021985lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021985s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2020	SUPPL-39	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021985s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021985Orig1s039ltr.pdf
11/14/2017	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021985s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021985Orig1s034ltr.pdf
11/04/2016	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021985s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021985Orig1s031ltr.pdf
12/22/2015	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021985Orig1s028ltr.pdf
03/27/2015	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021985Orig1s027ltr.pdf
03/18/2014	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021985s026lbl.pdf
11/04/2013	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021985s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021985Orig1s025ltr.pdf
09/28/2012	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985Orig1s024ltr.pdf
04/16/2012	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s023ltr.pdf
02/02/2012	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985Orig1s022LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s022ltrC.pdf
01/26/2012	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s021ltr.pdf
10/12/2011	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021985s019ltr.pdf
02/10/2011	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021985s014ltr.pdf
08/04/2010	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021985s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021985s012ltr.pdf
11/10/2009	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021985s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021985s008ltr.pdf
05/19/2008	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021985s006ltr.pdf
02/15/2008	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021985s004ltr.pdf
08/07/2007	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021985s002ltr.pdf

Labels for NDA 021985

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2020	SUPPL-39	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021985s039lbl.pdf
06/17/2020	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021985s039lbl.pdf
11/14/2017	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021985s034lbl.pdf
11/04/2016	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021985s031lbl.pdf
12/22/2015	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s028lbl.pdf
03/27/2015	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s027lbl.pdf
03/18/2014	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021985s026lbl.pdf
11/04/2013	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021985s025lbl.pdf
09/28/2012	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s024lbl.pdf
04/16/2012	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s023lbl.pdf
02/02/2012	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985Orig1s022LBL.pdf
01/26/2012	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s021lbl.pdf
10/12/2011	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s019lbl.pdf
02/10/2011	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s014lbl.pdf
08/04/2010	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021985s012lbl.pdf
11/10/2009	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021985s008lbl.pdf
03/05/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021985lbl.pdf

Therapeutic Equivalents for NDA 021985

TEKTURNA

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALISKIREN HEMIFUMARATE	ALISKIREN HEMIFUMARATE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	206665	ENDO OPERATIONS
TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 150MG BASE	TABLET;ORAL	Prescription	Yes	AB	021985	NODEN PHARMA

TABLET;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALISKIREN HEMIFUMARATE	ALISKIREN HEMIFUMARATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	206665	ENDO OPERATIONS
TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 300MG BASE	TABLET;ORAL	Prescription	Yes	AB	021985	NODEN PHARMA

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