← FDA Drug Approvals (Drugs@FDA)
BIVALIRUDIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN LABS LTD · Approved 2017-02-02
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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