# DABIGATRAN ETEXILATE MESYLATE
> **ANDA208046** · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC PHARMS LTD · Approved 2022-04-04
## Drug
- **FDA Application Number:** ANDA208046
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DABIGATRAN ETEXILATE MESYLATE
- **Generic name:** Dabigatran Etexilate Mesylate
- **Active ingredients:** DABIGATRAN ETEXILATE MESYLATE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** ALEMBIC PHARMS LTD
- **First approval:** 2022-04-04
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208046)
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