Drugs@FDA document

VANCOMYCIN HYDROCHLORIDE Review · NDA 209481 ORIG-1

Drugs@FDA document · MYLAN LABS LTD · Jan 7, 2019

Key facts

Drug name VANCOMYCIN HYDROCHLORIDE
Document type Review
Application NDA209481
Submission ORIG-1
Company MYLAN LABS LTD
Document date Jan 7, 2019
FDA document accessdata.fda.gov

At a glance

  • Microbiology Review Document categories
  • 10–99 Documents for this application
  • 1–9 USP chapters cited in this application's documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA documents

Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date:

Browse all Drugs@FDA documents