# DABIGATRAN ETEXILATE MESYLATE
> **ANDA208048** · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS · Approved 2025-01-28
## Drug
- **FDA Application Number:** ANDA208048
- **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:** DR REDDYS
- **Manufacturer:** Dr.Reddys Laboratories Inc
- **First approval:** 2025-01-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208048)
---
*MORVS · CC0 1.0*