Orange Book product · Brand (NDA)

VANCOMYCIN HYDROCHLORIDE

Brand (NDA)NDA 210274RX ZHEJIANG NOVUS PHARM

View VANCOMYCIN HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Jan 20, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jan 20, 2023
3 yr 6 mo ago
Today

Pharmaceutical detail

Active ingredient

VANCOMYCIN HYDROCHLORIDE

Strength

EQ 500MG BASE/VIAL

Dosage form

POWDER

Route

INTRAVENOUS, ORAL

TE code

Not listed

Application

NDA 210274

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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