# PRADAXA
> **NDA214358** · New Drug Application · Sponsor: BOEHRINGER INGELHEIM · Approved 2021-06-21
## Drug
- **FDA Application Number:** NDA214358
- **Application type:** New Drug Application
- **Brand name:** PRADAXA
- **Generic name:** DABIGATRAN ETEXILATE
- **Active ingredients:** DABIGATRAN ETEXILATE MESYLATE
- **Dosage form:** PELLETS
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** BOEHRINGER INGELHEIM
- **Manufacturer:** Boehringer Ingelheim Pharmaceuticals, Inc.
- **First approval:** 2021-06-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214358)
---
*MORVS · CC0 1.0*