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FDA NDA · NDA021386

ZOMETA

Sponsor: NOVARTIS

APPLICATION
NDA021386
TYPE
NDA
ORIGINAL APPROVAL
2002-02-22
LATEST ACTION
2011-02-04
ROUTE
IV (INFUSION)
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZOMETAPrescription
ZOLEDRONIC ACID EQ 4MG BASE/VIAL · INJECTABLE · IV (INFUSION)

Approval history

2011-02-04Labeling · Supplement 4 · unknown — Label ↗AP
2004-02-27Efficacy · Supplement 1 · standard — Label ↗AP
2002-02-22Type 6 - New Indication (no longer used) · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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