Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022545
Company: NOVARTIS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/26/2010 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022545s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022545s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022545_tekamlo_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022545Origs000SumR.pdf
Supplements
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, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022545s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022545Orig1s020ltr.pdf
12/22/2015 SUPPL-17 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s017ltr.pdf
03/27/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s016ltr.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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022545s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022545Orig1s014ltr.pdf
09/28/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013ltr.pdf
04/16/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s012ltr.pdf
09/28/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013ltr.pdf
02/02/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s010ltr.pdf
11/14/2011 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s008ltr.pdf
01/26/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s007lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s007ltr.pdf
10/12/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s005ltr.pdf
03/30/2011 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s001ltr.pdf
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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