← FDA DRUG APPROVALS

FDA NDA · NDA020570

QUADRAMET

Sponsor: LANTHEUS MEDICAL

APPLICATION
NDA020570
TYPE
NDA
ORIGINAL APPROVAL
1997-03-28
LATEST ACTION
2017-09-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

QUADRAMET · ReferenceDiscontinued
SAMARIUM SM-153 LEXIDRONAM PENTASODIUM 50mCi/ML · INJECTABLE · INJECTION

Approval history

2017-09-21Labeling · Supplement 8 · standard — Label ↗AP
2009-05-13Manufacturing (CMC) · Supplement 4 — Letter ↗AP
1999-04-12Labeling · Supplement 2 · standardAP
1998-01-29Manufacturing (CMC) · Supplement 1 · standardAP
1997-03-28Type 1 - New Molecular Entity · Original · standardAP
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 →