Vancomycin Hydrochloride

NDA 210274, held by Zhejiang Novus Pharm. Vancomycin Hydrochloride.

As of Nov 13, 2026, NDA 210274 (Vancomycin Hydrochloride), held by Zhejiang Novus Pharm, was first approved by FDA on Jan 20, 2023, with 2 approved supplements and 3 published complete response letters.

First approved: Jan 20, 2023
Review: Standard
Supplements approved: 2
Complete response letters: 3

What It's For

From the FDA-approved label (Indications and Usage)

Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of: o Septicemia o Infective Endocarditis o Skin and Skin Structure Infections o Bone Infections o Lower Respiratory Tract Infections Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of: o Clostridioides difficile -associated diarrhea o Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Limitations of Use Vancomycin Hydrochloride for Injection administered intravenously i…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 20, 2023	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Aug 25, 2021	Vancomycin HydrochlorideFacility Inspections	Approved
Nov 27, 2020	Vancomycin HydrochlorideFacility Inspections	Approved
Jun 15, 2018	Vancomycin HydrochlorideProduct Quality	Approved

Products

7 strengths and forms

Product	Active ingredient	Marketing
Vancomycin HydrochlorideEQ 500MG BASE/VIAL · powder;intravenous, oral	Vancomycin Hydrochloride	RxReference drug
Vancomycin HydrochlorideEQ 1GM BASE/VIAL · powder;intravenous, oral	Vancomycin Hydrochloride	RxReference drug
Vancomycin HydrochlorideEQ 5GM BASE/VIAL · powder;intravenous, oral	Vancomycin Hydrochloride	RxReference drug
Vancomycin HydrochlorideEQ 10GM BASE/VIAL · powder;intravenous, oral	Vancomycin Hydrochloride	RxReference drug
Vancomycin HydrochlorideEQ 750MG BASE/VIAL · powder;intravenous, oral	Vancomycin Hydrochloride	RxReference drug
Vancomycin HydrochlorideEQ 1.25GM BASE/VIAL · powder;intravenous, oral	Vancomycin Hydrochloride	RxReference drug
Vancomycin HydrochlorideEQ 1.5MG BASE/VIAL · powder;intravenous, oral	Vancomycin Hydrochloride	RxReference drug

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 29, 2025	Supplement 3Labeling · Standard review	Approved	Label Letter
Jul 30, 2024	Supplement 2Manufacturing	Approved	None posted
Jan 20, 2023	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 210274
Drugs@FDA: Overview at FDA
Company: Zhejiang Novus Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters