APPLICATION
NDA020460
TYPE
NDA
ORIGINAL APPROVAL
1994-12-22
LATEST ACTION
2002-09-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CYTOVENE · ReferenceDiscontinued
GANCICLOVIR 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
CYTOVENE · ReferenceDiscontinued
GANCICLOVIR 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2002-09-13Manufacturing (CMC) · Supplement 12 · priorityAP
2000-12-01Labeling · Supplement 10 · standardAP
2000-10-17Manufacturing (CMC) · Supplement 11 · priorityAP
1998-10-21Manufacturing (CMC) · Supplement 9 · priorityAP
1997-12-30Manufacturing (CMC) · Supplement 4 · priorityAP
1997-05-30Manufacturing (CMC) · Supplement 7 · priorityAP
1996-11-27Efficacy · Supplement 6 · standardAP
1995-10-27Efficacy · Supplement 5 · priorityAP
1995-07-20Manufacturing (CMC) · Supplement 2 · priorityAP
1995-03-01Labeling · Supplement 3 · standardAP
1994-12-22Type 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.
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