APPLICATION
NDA018299
TYPE
NDA
ORIGINAL APPROVAL
1980-04-10
LATEST ACTION
2018-03-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
VIROPTIC · ReferencePrescription
TRIFLURIDINE 1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2018-03-19Manufacturing (CMC) · Supplement 16AP
1997-10-17Labeling · Supplement 9 · standardAP
1997-03-06Manufacturing (CMC) · Supplement 10 · priorityAP
1997-02-10Manufacturing (CMC) · Supplement 13 · priorityAP
1996-12-31Manufacturing (CMC) · Supplement 12 · priorityAP
1996-12-10Manufacturing (CMC) · Supplement 11 · priorityAP
1995-05-08Manufacturing (CMC) · Supplement 8 · priorityAP
1991-12-30Labeling · Supplement 6AP
1988-12-05Labeling · Supplement 5AP
1983-03-14Manufacturing (CMC) · Supplement 4 · priorityAP
1981-08-20Manufacturing (CMC) · Supplement 3 · priorityAP
1980-12-30Manufacturing (CMC) · Supplement 2 · priorityAP
1980-06-27Manufacturing (CMC) · Supplement 1 · priorityAP
1980-04-10Type 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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