Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022512
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/19/2010 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022512s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022512Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022512Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2023 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022512s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022512Orig1s047ltr.pdf | |
| 04/20/2021 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022512s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022512Orig1s042ltr.pdf | |
| 06/21/2021 | SUPPL-41 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022512s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022512Orig1s041ltr.pdf | |
| 07/01/2020 | SUPPL-39 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022512s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022512Orig1s039ltr.pdf | |
| 11/22/2019 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022512s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022512Orig1s038ltr.pdf | |
| 03/13/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022512s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022512Orig1s035ltr.pdf | |
| 07/28/2016 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/2015 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s032ltr.pdf | |
| 08/26/2015 | SUPPL-31 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s031ltr.pdf | |
| 11/20/2015 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s028ltr.pdf | |
| 09/10/2015 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s027ltr.pdf | |
| 04/07/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/2014 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s025.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s025ltr.pdf | |
| 01/15/2015 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s024ltr.pdf | |
| 08/14/2014 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s023ltr.pdf | |
| 07/25/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/2013 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022512s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022512Orig1s021ltr.pdf | |
| 04/16/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/2014 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s018ltr.pdf | |
| 04/25/2013 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022512s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022512Orig1s017ltr.pdf | |
| 12/19/2012 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512Orig1s016ltr.pdf | |
| 11/20/2012 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2012 | SUPPL-14 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512Orig1s014ltr.pdf | |
| 05/31/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022512Orig1s011_replace.pdf | |
| 04/27/2012 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s010ltr.pdf | |
| 01/17/2012 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s009ltr.pdf | |
| 11/09/2011 | SUPPL-7 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s007ltr.pdf | |
| 04/05/2011 | SUPPL-5 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s005ltr.pdf |
| 03/04/2011 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022512Orig1s004.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/17/2023 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022512s047lbl.pdf | |
| 06/21/2021 | SUPPL-41 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022512s041lbl.pdf | |
| 04/20/2021 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022512s048lbl.pdf | |
| 07/01/2020 | SUPPL-39 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022512s039lbl.pdf | |
| 11/22/2019 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022512s038lbl.pdf | |
| 03/13/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022512s035lbl.pdf | |
| 11/20/2015 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s028lbl.pdf | |
| 10/23/2015 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s032lbl.pdf | |
| 09/10/2015 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s027lbl.pdf | |
| 08/26/2015 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512Orig1s031lbl.pdf | |
| 01/15/2015 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s024lbl.pdf | |
| 09/04/2014 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s025.pdf | |
| 08/14/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s023lbl.pdf | |
| 04/04/2014 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s018lbl.pdf | |
| 12/10/2013 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022512s021lbl.pdf | |
| 04/25/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022512s017lbl.pdf | |
| 12/19/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s016lbl.pdf | |
| 11/02/2012 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s014lbl.pdf | |
| 05/31/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s011lbl.pdf | |
| 04/27/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s010lbl.pdf | |
| 01/17/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s009lbl.pdf | |
| 11/09/2011 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s007lbl.pdf | |
| 03/04/2011 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s004lbl.pdf | |
| 10/19/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022512s000lbl.pdf |
PRADAXA
CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208040 | ALKEM LABS LTD |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208070 | APOTEX |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207961 | HETERO LABS LTD III |
| PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 022512 | BOEHRINGER INGELHEIM |
CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208040 | ALKEM LABS LTD |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208070 | APOTEX |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207961 | HETERO LABS LTD III |
| PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 022512 | BOEHRINGER INGELHEIM |
CAPSULE;ORAL; EQ 110MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208070 | APOTEX |
| PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 022512 | BOEHRINGER INGELHEIM |