Drug application
DABIGATRAN ETEXILATE MESYLATE (DABIGATRAN ETEXILATE MESYLATE)
Drugs@FDA ANDA 208057 · TEVA PHARMS USA
Key facts
| Drug name | DABIGATRAN ETEXILATE MESYLATE |
|---|---|
| Active ingredients | DABIGATRAN ETEXILATE MESYLATE |
| Application type | ANDA |
| Application number | 208057 |
| Company | TEVA PHARMS USA |
| Dosage forms | CAPSULE, ORAL |
| Strength | EQ 75MG BASE |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Apr 19, 2017 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No 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: