APPLICATION
NDA013934
TYPE
NDA
ORIGINAL APPROVAL
1964-04-06
LATEST ACTION
2001-09-17
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
STOXILDiscontinued
IDOXURIDINE 0.1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2001-09-17Labeling · Supplement 11AP
1987-06-25Labeling · Supplement 12AP
1980-02-20Labeling · Supplement 10AP
1979-05-03Labeling · Supplement 9AP
1976-04-29Labeling · Supplement 8AP
1964-04-06Type 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.