Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022512
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 None 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
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
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 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 207961 HETERO LABS LTD III
PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE;ORAL Prescription Yes AB 022512 BOEHRINGER INGELHEIM

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