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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210274
Company: ZHEJIANG NOVUS PHARM

Products on NDA 210274

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS, ORAL	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS, ORAL	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER;INTRAVENOUS, ORAL	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER;INTRAVENOUS, ORAL	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER;INTRAVENOUS, ORAL	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS, ORAL	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5MG BASE/VIAL	POWDER;INTRAVENOUS, ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210274

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210274s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210274Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/210274Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2025	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210274Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210274Orig1s003ltr.pdf
07/30/2024	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for NDA 210274

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2025	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210274Orig1s003lbl.pdf
05/29/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210274Orig1s003lbl.pdf
01/20/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210274s000lbl.pdf

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