APPLICATION
ANDA205749
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-29
LATEST ACTION
2020-12-08
ROUTE
INTRAVENOUS, IV (INFUSION)
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, None (Tentative Approval)
Products
ZOLEDRONICPrescription
ZOLEDRONIC ACID EQ 4MG BASE/100ML · INJECTABLE · INTRAVENOUS
ZOLEDRONIC ACIDNone (Tentative Approval)
ZOLEDRONIC ACID EQ 4MG BASE/100ML · INJECTABLE · IV (INFUSION)
Approval history
2020-12-08Labeling · Supplement 1 · standardAP
2018-06-29UNKNOWN · Original · standardAP
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.