APPLICATION
ANDA065432
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-30
LATEST ACTION
2021-06-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-06-04Labeling · Supplement 28 · standardAP
2020-08-19Labeling · Supplement 16 · standardAP
2020-08-19Labeling · Supplement 20 · standardAP
2020-08-19Labeling · Supplement 23 · standardAP
2020-08-19Labeling · Supplement 21 · standardAP
2009-06-23Labeling · Supplement 3AP
2009-06-23Labeling · Supplement 2AP
2008-12-30OriginalAP
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.