APPLICATION
ANDA065455
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-29
LATEST ACTION
2021-05-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
VANCOMYCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-05-24Labeling · Supplement 18 · standardAP
2020-08-28Labeling · Supplement 6 · standardAP
2020-08-28Labeling · Supplement 14 · standardAP
2009-04-29OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.