Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021985
Company: NODEN PHARMA
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 ANCHEN PHARMS
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 ANCHEN PHARMS
TEKTURNA ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET;ORAL Prescription Yes AB 021985 NODEN PHARMA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English