← FDA DRUG APPROVALS

FDA ANDA · ANDA206616

VANCOMYCIN HYDROCHLORIDE

Sponsor: HIKMA PHARMS

APPLICATION
ANDA206616
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-03
LATEST ACTION
2021-05-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2021-05-25Labeling · Supplement 3 · standardAP
2020-08-20Labeling · Supplement 1 · standardAP
2018-10-03UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →