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 21985

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

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