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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022011
Company: NOVARTIS

Medication Guide

Products on NDA 022011

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYZEKA	TELBIVUDINE	600MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022011

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/2006	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022011s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/22011s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2018	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011s022,022154s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022011Orig1s022,022154Orig1s019ltr.pdf
03/28/2018	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011S021_022154_S018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022011Orig1s021,022154Orig1s018ltr.pdf
12/11/2015	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/06/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/28/2013	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022011Orig1s013,022154Orig1s010ltr.pdf
12/23/2011	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011S012,022154S009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s012,022154s009ltr.pdf
05/05/2011	SUPPL-11	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s011,022154s008ltr.pdf
01/28/2013	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s010lbl.pdf
03/29/2011	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011s009,022154s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s009,022154s006ltr.pdf
09/10/2010	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s006,022154s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022154s003,022011s006ltr.pdf
03/04/2010	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s003,022154s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022011s003,022154s001ltr.pdf
05/08/2009	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022011s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022011s002ltr.pdf
01/23/2009	SUPPL-1	Efficacy-Labeling Change With Clinical Data, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022011s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022011s001ltr.pdf

Labels for NDA 022011

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2018	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011s022,022154s019lbl.pdf
03/28/2018	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011S021_022154_S018lbl.pdf
01/28/2013	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013lbl.pdf
01/28/2013	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s010lbl.pdf
12/23/2011	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011S012,022154S009lbl.pdf
03/29/2011	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011s009,022154s006lbl.pdf
09/10/2010	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s006,022154s003lbl.pdf
03/04/2010	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s003,022154s001lbl.pdf
05/08/2009	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022011s002lbl.pdf
01/23/2009	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022011s001lbl.pdf
01/23/2009	SUPPL-1	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022011s001lbl.pdf
10/25/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022011lbl.pdf

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