← FDA DRUG APPROVALS

FDA ANDA · ANDA091377

VANCOMYCIN HYDROCHLORIDE

Sponsor: XELLIA PHARMS APS

APPLICATION
ANDA091377
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-09
LATEST ACTION
2015-09-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

VANCOMYCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2015-09-09OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →