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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022107
Company: NODEN PHARMA

Summary Review

Products on NDA 022107

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEKTURNA HCT	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TEKTURNA HCT	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TEKTURNA HCT	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TEKTURNA HCT	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022107

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
09/28/2020	SUPPL-34	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022107s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022107Orig1s034ltr.pdf
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

Labels for NDA 022107

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2020	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022107s034lbl.pdf
09/28/2020	SUPPL-34	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022107s034lbl.pdf
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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