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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200045
Company: NOVARTIS

Summary Review

Products on NDA 200045

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200045

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

Labels for NDA 200045

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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