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Dabigatran (Pradaxa)

The Pradaxa brand of dabigatran, whose FDA application names Boehringer Ingelheim. The US Food and Drug Administration approved it in October 2010 to lower the stroke and systemic embolism risk of people with non-valvular atrial fibrillation.

Also called Pradaxa

  • Product
  • In this atlas

Overview

Technical summary

FDA NDA 022512, approved 2010-10-19 (approval letter), sponsor Boehringer Ingelheim in the openFDA record. The openFDA active ingredient is DABIGATRAN ETEXILATE MESYLATE; this atlas links it to the dabigatran substance. openFDA lists capsules and names Boehringer Ingelheim Pharmaceuticals Inc. as manufacturer, and this record links to the Boehringer Ingelheim organization record. The approval letter covers capsules of 75 mg and 150 mg.

Product details

Type
Medicine
Model or formulation
Oral capsules (openFDA product list)
Version
Original approval covered capsules of 75 mg and 150 mg (approval letter); other strengths now on the openFDA list are not described here

Intended-use sources

No intended-use source is recorded.

Claims and evidence

Context United States NDA NDA022512 approval for PRADAXA (dabigatran etexilate mesylate)

Recipient
Recipient not specified
Population
People with non-valvular atrial fibrillation (restated from the approval letter). The letter gives no other population details.
Care setting
Not stated in the FDA records
Geography
United States (decision by the US Food and Drug Administration)
Life stage
Not stated in the FDA records (they say people with atrial fibrillation and give no age)
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: inclusion criteria not stated; exclusion criteria not stated
Included
None stated
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    The US Food and Drug Administration approved NDA 022512 for PRADAXA (dabigatran etexilate mesylate) capsules, submitted by Boehringer Ingelheim Pharmaceuticals, Inc., on 19 October 2010. The approval letter covers PRADAXA capsules of 75 mg and 150 mg, with the indication of lowering the stroke and systemic embolism risk of people with non-valvular atrial fibrillation. The openFDA record lists the original submission as approved, with priority review, in the class Type 1 - New Molecular Entity.

    Applies to Recipient not specified
    • People with non-valvular atrial fibrillation (restated from the approval letter). The letter gives no other population details.
    • Not stated in the FDA records
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA records (they say people with atrial fibrillation and give no age)
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    Limitations
    The approval letter and the openFDA record state the regulatory decision and the indication, not how well the medicine works for any person. The trial evidence is on the dabigatran page (RE-LY). The letter covers the capsules of 75 mg and 150 mg named in it; the openFDA product list for the application now includes other strengths, which are not described here. openFDA data are unvalidated. The approval letter is a cite-only source until the integration owner confirms the terms for its host.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (13)

    1. Supports FDA drug application NDA022512 (openFDA Drugs@FDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. · NDA: NDA022512

      Locator
      results[0].application_number
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA022512.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    2. Supports FDA drug application NDA022512 (openFDA Drugs@FDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. · NDA: NDA022512

      Locator
      results[0].sponsor_name
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA022512.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    3. Supports FDA drug application NDA022512 (openFDA Drugs@FDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. · NDA: NDA022512

      Locator
      results[0].products[0].brand_name
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA022512.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    4. Supports FDA drug application NDA022512 (openFDA Drugs@FDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. · NDA: NDA022512

      Locator
      results[0].submissions[8].submission_status
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA022512.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    5. Supports FDA drug application NDA022512 (openFDA Drugs@FDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. · NDA: NDA022512

      Locator
      results[0].submissions[8].submission_class_code_description
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA022512.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    6. Supports FDA drug application NDA022512 (openFDA Drugs@FDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. · NDA: NDA022512

      Locator
      results[0].submissions[8].review_priority
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA022512.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    7. Supports FDA approval letter for NDA NDA022512

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.

      Locator
      Signature page, date (MM/DD/YYYY)
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2010-10-19
      Source state
      Current
      Snapshot hash
      965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA022512.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    8. Supports FDA approval letter for NDA NDA022512

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.

      Locator
      Page 1, paragraph 2
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2010-10-19
      Source state
      Current
      Snapshot hash
      965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA022512.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    9. Supports FDA approval letter for NDA NDA022512

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.

      Locator
      Page 1, addressee
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2010-10-19
      Source state
      Current
      Snapshot hash
      965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA022512.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    10. Supports FDA approval letter for NDA NDA022512

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.

      Locator
      Page 1, paragraph 4
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2010-10-19
      Source state
      Current
      Snapshot hash
      965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA022512.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    11. Supports FDA approval letter for NDA NDA022512

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.

      Locator
      Page 1, paragraph 4 (fragment 1 of 3)
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2010-10-19
      Source state
      Current
      Snapshot hash
      965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA022512.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    12. Supports FDA approval letter for NDA NDA022512

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.

      Locator
      Page 1, paragraph 4 (fragment 2 of 3)
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2010-10-19
      Source state
      Current
      Snapshot hash
      965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA022512.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    13. Supports FDA approval letter for NDA NDA022512

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.

      Locator
      Page 1, paragraph 4 (fragment 3 of 3)
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2010-10-19
      Source state
      Current
      Snapshot hash
      965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA022512.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

Authorization

Regulatory decision: Dabigatran (Pradaxa)

Applies to Recipient not specified
  • People with non-valvular atrial fibrillation (restated from the approval letter). The letter gives no other population details.
  • Not stated in the FDA records
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA records (they say people with atrial fibrillation and give no age)
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
NDA
Submission
NDA022512
Jurisdictions
United States; note: United States
Product version
Capsules of 75 mg and 150 mg (approval letter)
Indication
To lower the stroke and systemic embolism risk of people with non-valvular atrial fibrillation (approval letter, restated)
Basis
The US Food and Drug Administration approved NDA 022512 for PRADAXA (dabigatran etexilate mesylate) capsules, submitted by Boehringer Ingelheim Pharmaceuticals, Inc., on 19 October 2010. The approval letter covers PRADAXA capsules of 75 mg and 150 mg, with the indication of lowering the stroke and systemic embolism risk of people with non-valvular atrial fibrillation. The openFDA record lists the original submission as approved, with priority review, in the class Type 1 - New Molecular Entity.

Limitations. The approval letter and the openFDA record state the regulatory decision and the indication, not how well the medicine works for any person. The trial evidence is on the dabigatran page (RE-LY). The letter covers the capsules of 75 mg and 150 mg named in it; the openFDA product list for the application now includes other strengths, which are not described here. openFDA data are unvalidated. The approval letter is a cite-only source until the integration owner confirms the terms for its host.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:pradaxa
Content hash
d07560e779aad748ed3fcb1971199d515161ebc014e3a6dd08f02f766c37809d