Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022011
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYZEKA TELBIVUDINE 600MG TABLET;ORAL Discontinued None Yes 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
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
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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