Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022107
Company: NODEN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEKTURNA HCT ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE EQ 150MG BASE;12.5MG TABLET;ORAL Prescription None Yes No
TEKTURNA HCT ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE EQ 150MG BASE;25MG TABLET;ORAL Prescription None Yes No
TEKTURNA HCT ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;12.5MG TABLET;ORAL Prescription None Yes Yes
TEKTURNA HCT ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;25MG TABLET;ORAL Prescription None 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
01/18/2008 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022107s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022107_tekturna_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022107s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/04/2016 SUPPL-29 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022107s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022107Orig1s029ltr.pdf
12/21/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/22/2015 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s026ltr.pdf
03/27/2015 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s025ltr.pdf
03/18/2014 SUPPL-24 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022107s024lbl.pdf
11/04/2013 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022107s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022107Orig1s023ltr.pdf
09/28/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107Orig1s022ltr.pdf
04/16/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s021ltr.pdf
02/02/2012 SUPPL-19 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s019ltr.pdf
01/26/2012 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s017ltr.pdf
02/14/2012 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/22107s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s016ltr.pdf
10/12/2011 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s014ltr.pdf
06/14/2011 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s013ltr.pdf
02/10/2011 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s009ltr.pdf
08/09/2010 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022107s007ltr.pdf
05/22/2010 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022107s005ltr.pdf
07/16/2009 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022107s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022107s002ltr.pdf
07/17/2008 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022107s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/04/2016 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022107s029lbl.pdf
11/04/2016 SUPPL-29 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022107s029lbl.pdf
12/22/2015 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s026lbl.pdf
03/27/2015 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s025lbl.pdf
03/18/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022107s024lbl.pdf
11/04/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022107s023lbl.pdf
09/28/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s022lbl.pdf
04/16/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s021lbl.pdf
02/14/2012 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/22107s016lbl.pdf
01/26/2012 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s017lbl.pdf
10/12/2011 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s014lbl.pdf
06/14/2011 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s011s013lbl.pdf
02/10/2011 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s009lbl.pdf
08/09/2010 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s007lbl.pdf
05/22/2010 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s005lbl.pdf
07/16/2009 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022107s002lbl.pdf
01/18/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022107lbl.pdf

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