Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202155
Company: BRISTOL MYERS SQUIBB
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 |
|---|---|---|---|---|---|
| 10/12/2021 | SUPPL-34 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202155s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202155Orig1s034ltr.pdf | |
| 04/20/2021 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202155s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202155Orig1s032ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 10/12/2021 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202155s034lbl.pdf | |
| 10/12/2021 | SUPPL-34 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202155s034lbl.pdf | |
| 04/20/2021 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202155s032lbl.pdf | |
| 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 | 210066 | HETERO LABS LTD V |
| APIXABAN | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 209810 | IMPAX |
| APIXABAN | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 209898 | INDOCO |
| APIXABAN | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 210067 | MACLEODS PHARMS LTD |
| APIXABAN | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 210156 | TORRENT |
| 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 | 210066 | HETERO LABS LTD V |
| APIXABAN | APIXABAN | 5MG | TABLET;ORAL | Prescription | No | AB | 209810 | IMPAX |
| APIXABAN | APIXABAN | 5MG | TABLET;ORAL | Prescription | No | AB | 209898 | INDOCO |
| APIXABAN | APIXABAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210067 | MACLEODS PHARMS LTD |
| APIXABAN | APIXABAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210156 | TORRENT |
| ELIQUIS | APIXABAN | 5MG | TABLET;ORAL | Prescription | Yes | AB | 202155 | BRISTOL MYERS SQUIBB |