APPLICATION
NDA020569
TYPE
NDA
ORIGINAL APPROVAL
1996-03-04
LATEST ACTION
2000-04-18
ROUTE
IMPLANTATION
DOSAGE FORM
IMPLANT
MARKETING STATUS
Discontinued
Products
VITRASERTDiscontinued
GANCICLOVIR 4.5MG · IMPLANT · IMPLANTATION
Approval history
2000-04-18Manufacturing (CMC) · Supplement 6AP
1999-08-04Manufacturing (CMC) · Supplement 5AP
1999-05-14Manufacturing (CMC) · Supplement 4AP
1997-11-26Manufacturing (CMC) · Supplement 3AP
1997-10-17Manufacturing (CMC) · Supplement 2AP
1996-12-20Manufacturing (CMC) · Supplement 1AP
1996-03-04Type 3 - New Dosage Form · 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.
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.