Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022154
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYZEKA | TELBIVUDINE | 100MG/5ML | SOLUTION;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/27/2018 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011s022,022154s019lbl.pdf | |
| 03/28/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011S021_022154_S018lbl.pdf | |
| 01/28/2013 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013,022154s010lbl.pdf | |
| 12/23/2011 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011S012,022154S009lbl.pdf | |
| 03/29/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011s009,022154s006lbl.pdf | |
| 09/10/2010 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s006,022154s003lbl.pdf | |
| 03/04/2010 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s003,022154s001lbl.pdf | |
| 04/28/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022154lbl.pdf |