# DABIGATRAN ETEXILATE MESYLATE
> **ANDA207961** · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2020-05-06
## Drug
- **FDA Application Number:** ANDA207961
- **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:** HETERO LABS LTD III
- **Manufacturer:** XLCare Pharmaceuticals, Inc.
- **First approval:** 2020-05-06
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207961)
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