# Dabigatran (Pradaxa)

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

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Also called: Pradaxa

Browse, condition area: Stroke; Heart rhythm problems  

## In plain language

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.

## 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.

## Claims, with the population each applies to

## 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)

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: FDA drug application NDA022512 (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:NDA022512&limit=1>
     Locator: results\[0\].application\_number. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92.
     How it applies: Quote from the FDA record.
  2. Supports: FDA drug application NDA022512 (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:NDA022512&limit=1>
     Locator: results\[0\].sponsor\_name. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92.
     How it applies: Quote from the FDA record.
  3. Supports: FDA drug application NDA022512 (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:NDA022512&limit=1>
     Locator: results\[0\].products\[0\].brand\_name. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92.
     How it applies: Quote from the FDA record.
  4. Supports: FDA drug application NDA022512 (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:NDA022512&limit=1>
     Locator: results\[0\].submissions\[8\].submission\_status. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92.
     How it applies: Quote from the FDA record.
  5. Supports: FDA drug application NDA022512 (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:NDA022512&limit=1>
     Locator: results\[0\].submissions\[8\].submission\_class\_code\_description. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92.
     How it applies: Quote from the FDA record.
  6. Supports: FDA drug application NDA022512 (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:NDA022512&limit=1>
     Locator: results\[0\].submissions\[8\].review\_priority. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: f177bbbf563f7a618a90bdd79afe8c0bd8a1d69af042c12a98c6ef6f536fcd92.
     How it applies: Quote from the FDA record.
  7. Supports: FDA approval letter for NDA NDA022512 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf>
     Locator: Signature page, date (MM/DD/YYYY). Retrieved 2026-10-14T18:25:06Z. Source state: Current. Snapshot hash: 965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16.
     How it applies: Quote from the FDA record.
  8. Supports: FDA approval letter for NDA NDA022512 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf>
     Locator: Page 1, paragraph 2. Retrieved 2026-10-14T18:25:06Z. Source state: Current. Snapshot hash: 965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16.
     How it applies: Quote from the FDA record.
  9. Supports: FDA approval letter for NDA NDA022512 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf>
     Locator: Page 1, addressee. Retrieved 2026-10-14T18:25:06Z. Source state: Current. Snapshot hash: 965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16.
     How it applies: Quote from the FDA record.
  10. Supports: FDA approval letter for NDA NDA022512 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf>
     Locator: Page 1, paragraph 4. Retrieved 2026-10-14T18:25:06Z. Source state: Current. Snapshot hash: 965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16.
     How it applies: Quote from the FDA record.
  11. Supports: FDA approval letter for NDA NDA022512 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf>
     Locator: Page 1, paragraph 4 (fragment 1 of 3). Retrieved 2026-10-14T18:25:06Z. Source state: Current. Snapshot hash: 965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16.
     How it applies: Quote from the FDA record.
  12. Supports: FDA approval letter for NDA NDA022512 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf>
     Locator: Page 1, paragraph 4 (fragment 2 of 3). Retrieved 2026-10-14T18:25:06Z. Source state: Current. Snapshot hash: 965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16.
     How it applies: Quote from the FDA record.
  13. Supports: FDA approval letter for NDA NDA022512 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2010-10-19.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf>
     Locator: Page 1, paragraph 4 (fragment 3 of 3). Retrieved 2026-10-14T18:25:06Z. Source state: Current. Snapshot hash: 965c254195388e8908101afb1cba03139cd1d46e4ebd3b28eb0e900c797e9f16.
     How it applies: Quote from the FDA record.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-nda022512`

- Product: Dabigatran (Pradaxa) (`cardio:pradaxa`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2010-10-19
- Product version: Capsules of 75 mg and 150 mg (approval letter)
- Pathway: NDA
- Submission: NDA022512
- Indication: To lower the stroke and systemic embolism risk of people with non-valvular atrial fibrillation (approval letter, restated)
- Jurisdictions: United States; note: United States
- Applies to: 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)
- Basis: claim `cardio:claim-fda-nda022512-approval`

## Connected pages

- Active ingredient: Dabigatran (`cardio:dabigatran`)
- The openFDA record names Boehringer Ingelheim Pharmaceuticals Inc. as a manufacturer: Boehringer Ingelheim (`cardio:boehringer-ingelheim`)
- Filed under this front: Medicines (`cardio:front-medicines`)

## Provenance

Content hash: d07560e779aad748ed3fcb1971199d515161ebc014e3a6dd08f02f766c37809d
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14