# DABIGATRAN ETEXILATE MESYLATE
> **ANDA215233** · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2024-08-12
## Drug
- **FDA Application Number:** ANDA215233
- **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:** ALEMBIC
- **Manufacturer:** Alembic Pharmaceuticals Inc.
- **First approval:** 2024-08-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215233)
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