# BIVALIRUDIN
> **ANDA091468** · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN LABS LTD · Approved 2017-02-02
## Drug
- **FDA Application Number:** ANDA091468
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BIVALIRUDIN
- **Generic name:** Bivalirudin
- **Active ingredients:** BIVALIRUDIN
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** MYLAN LABS LTD
- **First approval:** 2017-02-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091468)
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