Orange Book product · Brand (NDA)

VANCOMYCIN HYDROCHLORIDE

Brand (NDA)NDA 209481TE APRX MYLAN LABS LTD

View VANCOMYCIN HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Jul 10, 2018

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jul 10, 2018
8 yr 1 mo ago
Today

Pharmaceutical detail

Active ingredient

VANCOMYCIN HYDROCHLORIDE

Strength

EQ 750MG BASE/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Application

NDA 209481

Product number

002

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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