approval · primary record
DABIGATRAN ETEXILATE MESYLATE
FDA · NDA · 2025-06-17
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-06-17 |
| Approval events | 1 |
| Brand | PRADAXA |
| Sponsor | BOEHRINGER INGELHEIM |
| Route | ORAL |
Approval history
1 action on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2025-06-17 | FDA | NDA | PRADAXA | BOEHRINGER INGELHEIM | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:32:15.309Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:dabigatran-etexilate-mesylate
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Dabigatran Etexilate Mesylate · compound