APPLICATION
NDA050486
TYPE
NDA
ORIGINAL APPROVAL
1976-11-26
LATEST ACTION
1999-07-26
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
VIRA-ADiscontinued
VIDARABINE 3% · OINTMENT · OPHTHALMIC
Approval history
1999-07-26Manufacturing (CMC) · Supplement 17 · priorityAP
1998-09-28Manufacturing (CMC) · Supplement 16 · priorityAP
1997-08-04Manufacturing (CMC) · Supplement 15 · priorityAP
1997-08-04Labeling · Supplement 11 · priorityAP
1997-08-04Labeling · Supplement 14 · priorityAP
1996-08-27Labeling · Supplement 13 · priorityAP
1981-04-29Labeling · Supplement 10 · priorityAP
1980-01-22Labeling · Supplement 8 · priorityAP
1979-12-20Manufacturing (CMC) · Supplement 7 · priorityAP
1978-06-05Manufacturing (CMC) · Supplement 6 · priorityAP
1978-03-15Labeling · Supplement 5 · priorityAP
1977-12-12Labeling · Supplement 12 · priorityAP
1977-11-15Labeling · Supplement 3 · priorityAP
1977-07-01Manufacturing (CMC) · Supplement 2 · priorityAP
1976-12-22Efficacy · Supplement 1 · priorityAP
1976-11-26Type 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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