# PRADAXA
> **NDA022512** · New Drug Application · Sponsor: BOEHRINGER INGELHEIM · Approved 2010-10-19
## Drug
- **FDA Application Number:** NDA022512
- **Application type:** New Drug Application
- **Brand name:** PRADAXA
- **Generic name:** DABIGATRAN ETEXILATE MESYLATE
- **Active ingredients:** DABIGATRAN ETEXILATE MESYLATE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** BOEHRINGER INGELHEIM
- **Manufacturer:** Boehringer Ingelheim Pharmaceuticals Inc.
- **First approval:** 2010-10-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022512)
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