← FDA DRUG APPROVALS

FDA NDA · NDA020140

FUSILEV

Sponsor: ACROTECH BIOPHARMA

APPLICATION
NDA020140
TYPE
NDA
ORIGINAL APPROVAL
2008-03-07
LATEST ACTION
2020-11-23
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION, POWDER
MARKETING STATUS
Discontinued

Products

FUSILEV · ReferenceDiscontinued
LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
FUSILEV · ReferenceDiscontinued
LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL · POWDER · INTRAVENOUS
FUSILEV · ReferenceDiscontinued
LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2020-11-23Labeling · Supplement 26 · standard — Label ↗AP
2020-02-11Labeling · Supplement 25 · standard — Letter ↗AP
2020-01-08Labeling · Supplement 24 · standard — Letter ↗AP
2014-06-24Manufacturing (CMC) · Supplement 18 · standardAP
2012-11-09Manufacturing (CMC) · Supplement 17 · standardAP
2011-04-29Efficacy · Supplement 2 · standard — Label ↗AP
2008-07-14Labeling · Supplement 1 · standard — Label ↗AP
2008-03-07Type 5 - New Formulation or New Manufacturer · Original · standard — 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.

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 →