APPLICATION
ANDA060707
TYPE
ANDA
ORIGINAL APPROVAL
1966-06-28
LATEST ACTION
1999-07-23
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription
Products
NEOSPORIN G.U. IRRIGANTDiscontinued
NEOMYCIN SULFATE EQ 40MG BASE/ML, POLYMYXIN B SULFATE 200,000 UNITS/ML · SOLUTION · IRRIGATION
NEOSPORIN G.U. IRRIGANT · ReferencePrescription
NEOMYCIN SULFATE EQ 800MG BASE/20ML, POLYMYXIN B SULFATE 4,000,000 UNITS/20ML (EQ 40MG BASE/ML · SOLUTION · IRRIGATION
Approval history
1999-07-23Manufacturing (CMC) · Supplement 2AP
1997-02-18Labeling · Supplement 1AP
1966-06-28OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.