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DALBAVANCIN HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2025-11-10
Drug application
- FDA Application #
ANDA217591- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DALBAVANCIN HYDROCHLORIDE
- Generic name
- DALBAVANCIN HYDROCHLORIDE
- Active ingredients
- DALBAVANCIN HYDROCHLORIDE
- Dosage form
- POWDER
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Sponsor
- FRESENIUS KABI USA
- Manufacturer
- Fresenius Kabi USA, LLC
- First approval
- 2025-11-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown