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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 AB Yes No

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
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