APPLICATION
NDA050456
TYPE
NDA
ORIGINAL APPROVAL
1974-03-12
LATEST ACTION
1997-09-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
STATROLDiscontinued
NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 16,250 UNITS/ML · SOLUTION/DROPS · OPHTHALMIC
Approval history
1995-11-01Manufacturing (CMC) · Supplement 19 · standardAP
1993-09-28Labeling · Supplement 3 · standardAP
1991-12-31Labeling · Supplement 1AP
1989-03-03Manufacturing (CMC) · Supplement 17 · standardAP
1987-05-15Manufacturing (CMC) · Supplement 15 · standardAP
1987-05-15Labeling · Supplement 16AP
1984-08-08Labeling · Supplement 14AP
1983-07-28Manufacturing (CMC) · Supplement 13 · standardAP
1982-01-11Manufacturing (CMC) · Supplement 12 · standardAP
1981-04-13Manufacturing (CMC) · Supplement 11 · standardAP
1978-09-21Manufacturing (CMC) · Supplement 10 · standardAP
1978-02-09Labeling · Supplement 9AP
1978-02-09Manufacturing (CMC) · Supplement 8 · standardAP
1977-03-01Manufacturing (CMC) · Supplement 7 · standardAP
1976-09-03Manufacturing (CMC) · Supplement 6 · standardAP
1976-03-01Manufacturing (CMC) · Supplement 5 · standardAP
1974-03-12Type 5 - New Formulation or New Manufacturer · Original · standardAP
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.