← FDA DRUG APPROVALS

FDA ANDA · ANDA207751

ZOLEDRONIC ACID

Sponsor: EUGIA PHARMA

APPLICATION
ANDA207751
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-26
LATEST ACTION
2020-02-21
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ZOLEDRONIC ACIDDiscontinued
ZOLEDRONIC ACID EQ 4MG BASE/5ML · INJECTABLE · INTRAVENOUS

Approval history

2020-02-21Labeling · Supplement 1 · standardAP
2020-02-21Labeling · Supplement 2 · standardAP
2016-09-26UNKNOWN · 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 →