APPLICATION
NDA013935
TYPE
NDA
ORIGINAL APPROVAL
1963-06-11
LATEST ACTION
1997-01-10
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
HERPLEXDiscontinued
IDOXURIDINE 0.1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
1997-01-10Manufacturing (CMC) · Supplement 30 · priorityAP
1996-04-02Manufacturing (CMC) · Supplement 29 · priorityAP
1995-08-03Manufacturing (CMC) · Supplement 28 · priorityAP
1989-11-08Manufacturing (CMC) · Supplement 27 · priorityAP
1988-10-17Labeling · Supplement 21AP
1982-08-13Manufacturing (CMC) · Supplement 24 · priorityAP
1982-04-08Manufacturing (CMC) · Supplement 19 · priorityAP
1982-04-08Manufacturing (CMC) · Supplement 20 · priorityAP
1981-12-09Manufacturing (CMC) · Supplement 23 · priorityAP
1981-05-15Manufacturing (CMC) · Supplement 22 · priorityAP
1979-12-18Manufacturing (CMC) · Supplement 18 · priorityAP
1979-10-23Manufacturing (CMC) · Supplement 17 · priorityAP
1978-01-18Manufacturing (CMC) · Supplement 14 · priorityAP
1977-11-29Manufacturing (CMC) · Supplement 15 · priorityAP
1977-08-22Labeling · Supplement 13AP
1977-04-28Labeling · Supplement 12AP
1976-07-12Labeling · Supplement 10AP
1976-03-03Labeling · Supplement 8AP
1976-03-03Manufacturing (CMC) · Supplement 9 · priorityAP
1963-06-11Type 1 - New Molecular Entity · Original · priorityAP
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.
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