Drug application
PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
Drugs@FDA NDA 022512 · BOEHRINGER INGELHEIM
Key facts
| Drug name | PRADAXA |
|---|---|
| Active ingredients | DABIGATRAN ETEXILATE MESYLATE |
| Application type | NDA |
| Application number | 022512 |
| Company | BOEHRINGER INGELHEIM |
| Dosage forms | CAPSULE, ORAL |
| Strength | EQ 75MG BASE |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | Yes |
| Latest submission class | Type 1 - New Molecular Entity |
| Latest submission status date | Oct 19, 2010 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- 10–99 Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: