# Apixaban (Eliquis)

Product · id `cardio:eliquis` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Also called: Eliquis

Browse, condition area: Stroke; Heart rhythm problems  

## In plain language

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.

## 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.

## Claims, with the population each applies to

## 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)

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: FDA drug application NDA202155 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202155&limit=1>
     Locator: results\[0\].application\_number. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: 4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec.
     How it applies: Quote from the FDA record.
  2. Supports: FDA drug application NDA202155 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202155&limit=1>
     Locator: results\[0\].sponsor\_name. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: 4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec.
     How it applies: Quote from the FDA record.
  3. Supports: FDA drug application NDA202155 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202155&limit=1>
     Locator: results\[0\].products\[0\].brand\_name. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: 4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec.
     How it applies: Quote from the FDA record.
  4. Supports: FDA drug application NDA202155 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202155&limit=1>
     Locator: results\[0\].submissions\[4\].submission\_status. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: 4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec.
     How it applies: Quote from the FDA record.
  5. Supports: FDA drug application NDA202155 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202155&limit=1>
     Locator: results\[0\].submissions\[4\].submission\_class\_code\_description. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: 4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec.
     How it applies: Quote from the FDA record.
  6. Supports: FDA drug application NDA202155 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202155&limit=1>
     Locator: results\[0\].submissions\[4\].review\_priority. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: 4d13d5dc7f73a9a15c48573a0ba3a3bea9a54785a8f85d84fb19e5c8512cddec.
     How it applies: Quote from the FDA record.
  7. Supports: FDA approval letter for NDA NDA202155 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202155Orig1s000ltr.pdf>
     Locator: Signature page, date (MM/DD/YYYY). Retrieved 2026-10-14T18:25:05Z. Source state: Current. Snapshot hash: f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011.
     How it applies: Quote from the FDA record.
  8. Supports: FDA approval letter for NDA NDA202155 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202155Orig1s000ltr.pdf>
     Locator: Page 1, paragraph 2. Retrieved 2026-10-14T18:25:05Z. Source state: Current. Snapshot hash: f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011.
     How it applies: Quote from the FDA record.
  9. Supports: FDA approval letter for NDA NDA202155 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202155Orig1s000ltr.pdf>
     Locator: Page 1, addressee. Retrieved 2026-10-14T18:25:05Z. Source state: Current. Snapshot hash: f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011.
     How it applies: Quote from the FDA record.
  10. Supports: FDA approval letter for NDA NDA202155 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202155Orig1s000ltr.pdf>
     Locator: Page 1, paragraph 5. Retrieved 2026-10-14T18:25:05Z. Source state: Current. Snapshot hash: f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011.
     How it applies: Quote from the FDA record.
  11. Supports: FDA approval letter for NDA NDA202155 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2012-12-28.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202155Orig1s000ltr.pdf>
     Locator: Page 1, indication. Retrieved 2026-10-14T18:25:05Z. Source state: Current. Snapshot hash: f865fec50b4a9a4d2267f85e5b1d949e6b3669618910552d2640f14883e0c011.
     How it applies: Quote from the FDA record.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-nda202155`

- Product: Apixaban (Eliquis) (`cardio:eliquis`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2012-12-28
- Product version: Tablets of 2.5 mg and 5 mg (approval letter)
- Pathway: NDA
- Submission: NDA202155
- Indication: To lower the stroke and systemic embolism risk of people with nonvalvular atrial fibrillation (approval letter, restated)
- Jurisdictions: United States; note: United States
- Applies to: 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)
- Basis: claim `cardio:claim-fda-nda202155-approval`

## Connected pages

- Active ingredient: Apixaban (`cardio:apixaban`)
- Filed under this front: Medicines (`cardio:front-medicines`)

## Provenance

Content hash: a08167bd24541ba3bc64ae09a223d4783385956053b0accca5b8c958f572737b
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14