APPLICATION
ANDA200918
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-21
LATEST ACTION
2017-12-14
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ZOLEDRONIC ACIDPrescription
ZOLEDRONIC ACID EQ 5MG BASE/100ML · INJECTABLE · INTRAVENOUS
Approval history
2017-12-14Labeling · Supplement 1 · standardAP
2014-08-21Not Applicable · OriginalAP
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.