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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022545
Company: NOVARTIS

Summary Review

Products on NDA 22545

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	EQ 150MG BASE;EQ 5MG BASE	TABLET;ORAL	Discontinued	None	No	No
TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	EQ 150MG BASE;EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No
TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	EQ 300MG BASE;EQ 5MG BASE	TABLET;ORAL	Discontinued	None	No	No
TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	EQ 300MG BASE;EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 022545

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2016	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022545s020lbl.pdf
11/04/2016	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022545s020lbl.pdf
12/22/2015	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s017lbl.pdf
12/22/2015	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s017lbl.pdf
03/27/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s016lbl.pdf
03/18/2014	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022545s015lbl.pdf
11/04/2013	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022545s014lbl.pdf
09/28/2012	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf
09/28/2012	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf
04/16/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s012lbl.pdf
02/02/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s010lbl.pdf
01/26/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s007lbledt.pdf
11/14/2011	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s008lbl.pdf
10/12/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s005lbl.pdf
03/30/2011	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s001lbl.pdf
08/26/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022545s000lbl.pdf

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