APPLICATION
NDA050081
TYPE
NDA
ORIGINAL APPROVAL
1963-05-10
LATEST ACTION
2003-03-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued
Products
POLY-PREDDiscontinued
NEOMYCIN SULFATE EQ 0.35% BASE, POLYMYXIN B SULFATE 10,000 UNITS/ML, PREDNISOLONE ACETATE 0.5% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2003-03-19Labeling · Supplement 38 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 36AP
2002-02-21Manufacturing (CMC) · Supplement 35AP
2001-04-12Manufacturing (CMC) · Supplement 32AP
2000-10-02Manufacturing (CMC) · Supplement 31AP
1998-05-19Manufacturing (CMC) · Supplement 30AP
1995-08-03Manufacturing (CMC) · Supplement 15AP
1994-03-07Manufacturing (CMC) · Supplement 13AP
1987-08-17Manufacturing (CMC) · Supplement 11AP
1985-12-12Manufacturing (CMC) · Supplement 9AP
1985-11-01Manufacturing (CMC) · Supplement 5AP
1985-09-04Manufacturing (CMC) · Supplement 8AP
1984-05-15Labeling · Supplement 3AP
1984-02-10Manufacturing (CMC) · Supplement 6AP
1983-10-18Manufacturing (CMC) · Supplement 4AP
1982-10-26Manufacturing (CMC) · Supplement 1AP
1982-08-02Manufacturing (CMC) · Supplement 29AP
1981-06-30Manufacturing (CMC) · Supplement 28AP
1980-03-18Manufacturing (CMC) · Supplement 25AP
1979-11-16Labeling · Supplement 24AP
1965-12-02Labeling · Supplement 18AP
1964-06-23Manufacturing (CMC) · Supplement 10AP
1963-10-23Labeling · Supplement 7AP
1963-05-10UNKNOWN · Original · unknownAP
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.