← FDA DRUG APPROVALS

FDA NDA · NDA210274

VANCOMYCIN HYDROCHLORIDE

Sponsor: ZHEJIANG NOVUS PHARM

APPLICATION
NDA210274
TYPE
NDA
ORIGINAL APPROVAL
2023-01-20
LATEST ACTION
2025-05-29
ROUTE
INTRAVENOUS, ORAL, INTRAVENOUS, ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.5MG BASE/VIAL · POWDER · INTRAVENOUS, ORAL
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL · POWDER · INTRAVENOUS, ORAL
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL · POWDER · INTRAVENOUS, ORAL
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · POWDER · INTRAVENOUS, ORAL
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL · POWDER · INTRAVENOUS, ORAL
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL · POWDER · INTRAVENOUS, ORAL
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · POWDER · INTRAVENOUS, ORAL

Approval history

2025-05-29Labeling · Supplement 3 · standard — Letter ↗AP
2024-07-30Manufacturing (CMC) · Supplement 2AP
2023-01-20Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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