Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200045
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET;ORAL Discontinued None No No
AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET;ORAL Discontinued None No No
AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET;ORAL Discontinued None No No
AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET;ORAL Discontinued None No No
AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;EQ 10MG BASE;25MG 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
12/21/2010 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200045s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200045s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045s000_amturnide_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/04/2016 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200045s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200045Orig1s020ltr.pdf
12/22/2015 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200045Orig1s017ltr.pdf
03/27/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200045Orig1s016ltr.pdf
03/18/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200045s015lbl.pdf
11/04/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200045s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200045Orig1s014ltr.pdf
09/28/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s011,s013ltr.pdf
04/18/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s012ltr_rev1rev2nh_Redacted.pdf
09/28/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s011,s013ltr.pdf
02/02/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s010ltr.pdf
11/02/2011 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s009ltr.pdf
01/26/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s007ltr.pdf
02/14/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s006ltr.pdf
10/12/2011 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s003,s004ltr.pdf
10/12/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s003,s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/04/2016 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200045s020lbl.pdf
12/22/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s017lbl.pdf
03/27/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s016lbl.pdf
03/18/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200045s015lbl.pdf
11/04/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200045s014lbl.pdf
09/28/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf
09/28/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf
04/18/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s012lbl.pdf
02/14/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s006lbl.pdf
02/02/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s010lbl.pdf
01/26/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s007lbl.pdf
11/02/2011 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s009lbl.pdf
10/12/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf
10/12/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf
12/21/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200045s000lbl.pdf

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