# BIVALIRUDIN
> **ANDA091206** · Abbreviated New Drug Application (Generic) · Sponsor: PLIVA HRVATSKA DOO · Approved 2016-09-14
## Drug
- **FDA Application Number:** ANDA091206
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BIVALIRUDIN
- **Generic name:** Bivalirudin
- **Active ingredients:** BIVALIRUDIN
- **Dosage form:** INJECTABLE
- **Route:** INTRAVENOUS
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** PLIVA HRVATSKA DOO
- **First approval:** 2016-09-14
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091206)
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*MORVS · CC0 1.0*