Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021797
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BARACLUDE | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| BARACLUDE | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2026 | SUPPL-27 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021797s027lbl.pdf | |
| 11/06/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021797s023,021798s024lbl.pdf | |
| 12/20/2018 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s021,021798s023lbl.pdf | |
| 12/20/2018 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s021,021798s023lbl.pdf | |
| 06/22/2018 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s019lbl.pdf | |
| 06/22/2018 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s019lbl.pdf | |
| 03/20/2014 | SUPPL-18 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021797s018,021798s019lbl.pdf | |
| 12/19/2013 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.pdf | |
| 12/19/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.pdf | |
| 12/19/2013 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.pdf | |
| 10/12/2012 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf | |
| 10/12/2012 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf | |
| 12/28/2010 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s011lbl.pdf | |
| 10/15/2010 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s010,021798s011lbl.pdf | |
| 07/16/2009 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s008, 021798s008lbl.pdf | |
| 02/25/2009 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s009,021798s010lbl.pdf | |
| 07/25/2008 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021797s005,021798s006lbl.pdf | |
| 07/24/2007 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s003,021798s003lbl.pdf | |
| 03/27/2007 | SUPPL-2 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s002,021798s002lbl.pdf | |
| 02/23/2007 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s001,021798s001lbl.pdf | |
| 03/29/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021797,021798lbl.pdf |