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DALBAVANCIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: KINDOS · Approved 2025-11-26

Drug application

FDA Application #
ANDA218929
Application type
Abbreviated New Drug Application (Generic)
Brand name
DALBAVANCIN HYDROCHLORIDE
Generic name
DALBAVANCIN
Active ingredients
DALBAVANCIN HYDROCHLORIDE
Dosage form
POWDER
Route
INTRAVENOUS
Marketing status
Prescription
Sponsor
KINDOS
Manufacturer
Meitheal Pharmaceuticals Inc
First approval
2025-11-26

Source

Authoritative
Drugs@FDA application overview
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