APPLICATION
ANDA217591
TYPE
ANDA
ORIGINAL APPROVAL
2025-11-10
LATEST ACTION
2025-11-10
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
DALBAVANCIN HYDROCHLORIDEPrescription
DALBAVANCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · POWDER · INTRAVENOUS
Approval history
2025-11-10UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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