← FDA DRUG APPROVALS

FDA NDA · NDA021817

RECLAST

zoledronic acid

Sponsor: SANDOZ

APPLICATION
NDA021817
TYPE
NDA
ORIGINAL APPROVAL
2007-04-16
LATEST ACTION
2026-02-03
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RECLAST · ReferencePrescription
ZOLEDRONIC ACID EQ 5MG BASE/100ML · INJECTABLE · INTRAVENOUS

Approval history

2026-02-03Labeling · Supplement 32 · standard — Letter ↗AP
2020-04-29Labeling · Supplement 28 · standard — Letter ↗AP
2017-07-07Labeling · Supplement 27 · standard — Label ↗AP
2016-05-24Manufacturing (CMC) · Supplement 23 · priorityAP
2016-04-14Labeling · Supplement 22 · standard — Label ↗AP
2015-04-16Labeling · Supplement 21 · standard — Label ↗AP
2015-01-30Labeling · Supplement 20 · standard — Letter ↗AP
2014-06-17Manufacturing (CMC) · Supplement 19 · priorityAP
2014-05-13Manufacturing (CMC) · Supplement 18 · priorityAP
2013-09-17Manufacturing (CMC) · Supplement 17 · priorityAP
2013-07-23Manufacturing (CMC) · Supplement 14 · priorityAP
2013-04-19Labeling · Supplement 15 · standard — Letter ↗AP
2011-08-31Labeling · Supplement 12 · unknown — Label ↗AP
2011-08-15REMS · Supplement 13 — Letter ↗AP
2011-03-08Labeling · Supplement 6 · unknown — Label ↗AP
2011-01-25REMS · Supplement 9 — Label ↗AP
2009-05-29Efficacy · Supplement 4 · unknown — Letter ↗AP
2009-03-13Efficacy · Supplement 3 · unknown — Letter ↗AP
2008-12-19Efficacy · Supplement 2 · unknown — Letter ↗AP
2008-06-03Efficacy · Supplement 1 · standard — Label ↗AP
2007-04-16Type 3 - New Dosage Form · Original · priority — Letter ↗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.

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 →