Viewing data from:

VANCOMYCIN HYDROCHLORIDE

NDA

VANCOMYCIN HYDROCHLORIDE | N210274 | ZHEJIANG NOVUS PHARMACEUTICALS CO LTD

7 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain10 active DMFs8 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

XELLIA PHARMACEUTICALS APSVANCOMYCIN HYDROCHLORIDE

DMF 136911998

HOSPIRA INCVANCOMYCIN HYDROCHLORIDE

DMF 137091998

XELLIA PHARMACEUTICALS LTDVANCOMYCIN HYDROCHLORIDE

DMF 137941998

LEK PHARMACEUTICALS DDVANCOMYCIN HYDROCHLORIDE

DMF 174782004

ZHEJIANG MEDICINE CO LTDVANCOMYCIN HYDROCHLORIDE USP (NON-STERILE API)

DMF 188902005

XELLIA PHARMACEUTICALS APSVANCOMYCIN HYDROCHLORIDE

DMF 206142007

CONCORD BIOTECH LTDVANCOMYCIN HYDROCHLORIDE USP

DMF 225282009

CHONGQING DAXIN PHARMACEUTICAL CO LTDVANCOMYCIN HYDROCHLORIDE

DMF 241852010

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDVANCOMYCIN HYDROCHLORIDE

DMF 263102012

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDVANCOMYCIN HYDROCHLORIDE

DMF 297292015

LEK PHARMACEUTICALS DDInactiveVANCOMYCIN HYDROCHLORIDE

DMF 132231998

ELI LILLY AND COInactiveVANCOMYCIN HYDROCHLORIDE

DMF 136521998

LEDERLE LABORATORIESInactiveVANCOMYCIN HYDROCHLORIDE

DMF 136891998

FUJISAWA PHARMACEUTICAL COInactiveVANCOMYCIN HYDROCHLORIDE

DMF 136941998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveVANCOMYCIN HYDROCHLORIDE USP (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 184972005

CQ INTERNATIONAL CO INCInactiveVANCOMYCIN HYDROCHLORIDE

DMF 235942010

JIANGSU HIBROAD BIO-PHARMACEUTICAL CO LTDInactiveVANCOMYCIN HYDROCHLORIDE

DMF 280792015

CKD BIO CORPInactiveVANCOMYCIN HYDROCHLORIDE

DMF 310022016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 30, 2025	SUPPL -3	View Letter (PDF)
Jan 23, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — EQ 500MG BASE/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS, ORAL | Approved: Jan 20, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS, ORAL | Approved: Jan 20, 2023

#003 — EQ 5GM BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS, ORAL | Approved: Jan 20, 2023

#004 — EQ 10GM BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS, ORAL | Approved: Jan 20, 2023

#005 — EQ 750MG BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS, ORAL | Approved: Aug 1, 2025

#006 — EQ 1.25GM BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS, ORAL | Approved: Aug 1, 2025

#007 — EQ 1.5MG BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS, ORAL | Approved: Aug 1, 2025