# DABIGATRAN ETEXILATE MESYLATE
> **ANDA208040** · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2020-03-11
## Drug
- **FDA Application Number:** ANDA208040
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DABIGATRAN ETEXILATE MESYLATE
- **Generic name:** DABIGATRAN ETEXILATE
- **Active ingredients:** DABIGATRAN ETEXILATE MESYLATE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ALKEM LABS LTD
- **Manufacturer:** Major Pharmaceuticals
- **First approval:** 2020-03-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208040)
---
*MORVS · CC0 1.0*