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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/29/2005 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021797,021798lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021797,021798ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21797_21798_BaracludeTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/06/2019 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021797s023,021798s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021797Orig1s023, 021798Orig1s024ltr.pdf | |
| 12/20/2018 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s021,021798s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021797Orig1s021, 021798Orig1s023Ltr.pdf | |
| 06/22/2018 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021797Orig1s19_21798Orig11s021ltr.pdf | |
| 03/20/2014 | SUPPL-18 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021797s018,021798s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021797Orig1s18,021798Orig1s19ltr.pdf | |
| 12/19/2013 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021797Orig1s017,021798Orig1s018ltr.pdf | |
| 06/18/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/2012 | SUPPL-14 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf | |
| 10/12/2012 | SUPPL-13 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf | |
| 12/28/2010 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021797s011,021798s012ltr.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 | |
| 02/25/2009 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s009,021798s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s009,021798s010ltr.pdf | |
| 07/16/2009 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s008, 021798s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s008,021798s008ltr.pdf | |
| 06/03/2008 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s006, 021798s007ltr.pdf |
| 07/25/2008 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021797s005,021798s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s005, 021798s006ltr.pdf | |
| 07/24/2007 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s003,021798s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s003, 021798s003ltr.pdf | |
| 03/27/2007 | SUPPL-2 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s002,021798s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s002, 021798s002ltr.pdf | |
| 02/23/2007 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s001,021798s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s001,021798s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s021,021798s023lbl.pdf | |
| 12/20/2018 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s021,021798s023lbl.pdf | |
| 06/22/2018 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s019lbl.pdf | |
| 06/22/2018 | SUPPL-19 | Labeling-Package Insert | 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-Container/Carton Labels | 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-Patient Package Insert | 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 |
BARACLUDE
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BARACLUDE | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 021797 | BRISTOL MYERS SQUIBB |
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 206652 | AMNEAL PHARMS |
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 206217 | AUROBINDO PHARMA |
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 208721 | BRECKENRIDGE |
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 212126 | BRIGHTGENE |
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 206872 | CIPLA |
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 205740 | HETERO LABS LTD V |
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 208782 | PRINSTON INC |
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 212106 | VITRUVIAS |
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 206745 | ZYDUS PHARMS |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BARACLUDE | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | Yes | AB | 021797 | BRISTOL MYERS SQUIBB |
| ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 206652 | AMNEAL PHARMS |
| ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 206217 | AUROBINDO PHARMA |
| ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 208721 | BRECKENRIDGE |
| ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 212126 | BRIGHTGENE |
| ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 206872 | CIPLA |
| ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 205740 | HETERO LABS LTD V |
| ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 208782 | PRINSTON INC |
| ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 212106 | VITRUVIAS |
| ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 206745 | ZYDUS PHARMS |