Cardiovascular Atlas
About
Menu

Apixaban (Eliquis)

The Eliquis brand of apixaban, whose FDA application names Bristol-Myers Squibb. The US Food and Drug Administration approved it in December 2012 to lower the stroke and systemic embolism risk of people with nonvalvular atrial fibrillation.

Also called Eliquis

  • Product
  • In this atlas

Overview

Technical summary

FDA NDA 202155, approved 2012-12-28 (approval letter), sponsor Bristol Myers Squibb in the openFDA record. openFDA lists tablets and tablets for oral suspension. The approval letter covers tablets of 2.5 mg and 5 mg. The openFDA record names no manufacturer, and this page links no company record.

Product details

Type
Medicine
Model or formulation
Oral tablets and tablets for oral suspension (openFDA product list)
Version
Original approval covered tablets of 2.5 mg and 5 mg (approval letter); later strengths and forms are not described here

Intended-use sources

No intended-use source is recorded.

Claims and evidence

Context United States NDA NDA202155 approval for ELIQUIS (apixaban)

Recipient
Recipient not specified
Population
People with nonvalvular 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 202155 for ELIQUIS (apixaban) tablets of 2.5 mg and 5 mg, submitted by Bristol-Myers Squibb, on 28 December 2012. The approval letter states the indication as lowering the stroke and systemic embolism risk of people with nonvalvular 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 nonvalvular 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 apixaban page (ARISTOTLE). The letter covers the tablets of 2.5 mg and 5 mg named in it, and later supplements and other product forms 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 (11)

    1. Supports FDA drug application NDA202155 (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: NDA202155

      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
      4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec
      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-NDA202155.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    2. Supports FDA drug application NDA202155 (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: NDA202155

      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
      4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec
      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-NDA202155.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    3. Supports FDA drug application NDA202155 (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: NDA202155

      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
      4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec
      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-NDA202155.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    4. Supports FDA drug application NDA202155 (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: NDA202155

      Locator
      results[0].submissions[4].submission_status
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec
      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-NDA202155.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    5. Supports FDA drug application NDA202155 (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: NDA202155

      Locator
      results[0].submissions[4].submission_class_code_description
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec
      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-NDA202155.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    6. Supports FDA drug application NDA202155 (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: NDA202155

      Locator
      results[0].submissions[4].review_priority
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec
      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-NDA202155.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    7. Supports FDA approval letter for NDA NDA202155

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.

      Locator
      Signature page, date (MM/DD/YYYY)
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2012-12-28
      Source state
      Current
      Snapshot hash
      f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA202155.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 NDA202155

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.

      Locator
      Page 1, paragraph 2
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2012-12-28
      Source state
      Current
      Snapshot hash
      f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA202155.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 NDA202155

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.

      Locator
      Page 1, addressee
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2012-12-28
      Source state
      Current
      Snapshot hash
      f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA202155.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 NDA202155

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.

      Locator
      Page 1, paragraph 5
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2012-12-28
      Source state
      Current
      Snapshot hash
      f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA202155.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 NDA202155

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.

      Locator
      Page 1, indication
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2012-12-28
      Source state
      Current
      Snapshot hash
      f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA202155.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: Apixaban (Eliquis)

Applies to Recipient not specified
  • People with nonvalvular 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
NDA202155
Jurisdictions
United States; note: United States
Product version
Tablets of 2.5 mg and 5 mg (approval letter)
Indication
To lower the stroke and systemic embolism risk of people with nonvalvular atrial fibrillation (approval letter, restated)
Basis
The US Food and Drug Administration approved NDA 202155 for ELIQUIS (apixaban) tablets of 2.5 mg and 5 mg, submitted by Bristol-Myers Squibb, on 28 December 2012. The approval letter states the indication as lowering the stroke and systemic embolism risk of people with nonvalvular 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 apixaban page (ARISTOTLE). The letter covers the tablets of 2.5 mg and 5 mg named in it, and later supplements and other product forms 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:eliquis
Content hash
a08167bd24541ba3bc64ae09a223d4783385956053b0accca5b8c958f572737b