Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202155
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELIQUIS APIXABAN 2.5MG TABLET;ORAL Prescription AB Yes No
ELIQUIS APIXABAN 5MG 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
12/28/2012 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202155Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202155Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/26/2019 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202155s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202155Orig1s024ltr.pdf
06/03/2019 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202155s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202155Orig1s021ltr.pdf
06/28/2018 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202155Orig1s020ltr.pdf
02/09/2018 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202155Orig1s018ltr.pdf
11/29/2017 SUPPL-17 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202155s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202155Orig1s017ltr.pdf
03/02/2016 SUPPL-14 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202155Orig1s014ltr.pdf
05/03/2016 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/202155Orig1s013.pdf
07/20/2016 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202155s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202155Orig1s012ltr.pdf
09/10/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202155Orig1s011ltr.pdf
06/16/2015 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202155Orig1s010ltr.pdf
08/12/2014 SUPPL-9 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s009ltr.pdf
05/01/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/30/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/21/2014 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s006ltr.pdf
03/09/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/31/2013 SUPPL-4 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202155Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202155Orig1s004ltr.pdf
03/13/2014 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s003ltr.pdf
01/30/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202155Orig1s002TOC.cfm
07/16/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/26/2019 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202155s024lbl.pdf
06/03/2019 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202155s021lbl.pdf
06/28/2018 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s020lbl.pdf
02/09/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s018lbl.pdf
11/29/2017 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202155s017lbl.pdf
07/20/2016 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202155s012lbl.pdf
09/10/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s011lbl.pdf
06/16/2015 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s010lbl.pdf
08/21/2014 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s006lbl.pdf
08/12/2014 SUPPL-9 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s009lbl.pdf
03/13/2014 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s003lbl.pdf
01/30/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s002lbl.pdf
10/31/2013 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202155Orig1s004lbl.pdf
12/28/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf

ELIQUIS

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APIXABAN APIXABAN 2.5MG TABLET;ORAL Prescription No AB 210180 ACCORD HLTHCARE
APIXABAN APIXABAN 2.5MG TABLET;ORAL Prescription No AB 209898 INDOCO
ELIQUIS APIXABAN 2.5MG TABLET;ORAL Prescription Yes AB 202155 BRISTOL MYERS SQUIBB

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APIXABAN APIXABAN 5MG TABLET;ORAL Prescription No AB 210180 ACCORD HLTHCARE
APIXABAN APIXABAN 5MG TABLET;ORAL Prescription No AB 209898 INDOCO
ELIQUIS APIXABAN 5MG TABLET;ORAL Prescription Yes AB 202155 BRISTOL MYERS SQUIBB

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