Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021797
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 205824 ACCORD HLTHCARE
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 206652 AMNEAL PHARMS
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 206217 AUROBINDO PHARMA LTD
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 206672 CASI PHARMS INC
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 211978 SUNSHINE LAKE
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 202122 TEVA PHARMS USA
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 205824 ACCORD HLTHCARE
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206652 AMNEAL PHARMS
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206217 AUROBINDO PHARMA LTD
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 206672 CASI PHARMS INC
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 211978 SUNSHINE LAKE
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 202122 TEVA PHARMS USA
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206745 ZYDUS PHARMS

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