← FDA Drug Approvals (Drugs@FDA)
BIVALIRUDIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2016-10-28
Drug application
- FDA Application #
ANDA090189- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BIVALIRUDIN
- Generic name
- BIVALIRUDIN
- Active ingredients
- BIVALIRUDIN
- Dosage form
- INJECTABLE
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Sponsor
- FRESENIUS KABI USA
- Manufacturer
- Fresenius Kabi USA, LLC
- First approval
- 2016-10-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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