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FDA NDA · NDA019661

CYTOVENE

Sponsor: CHEPLAPHARM

APPLICATION
NDA019661
TYPE
NDA
ORIGINAL APPROVAL
1989-06-23
LATEST ACTION
2020-05-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CYTOVENE · ReferenceDiscontinued
GANCICLOVIR SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2020-05-20Labeling · Supplement 38 · standard — Letter ↗AP
2018-08-06Efficacy · Supplement 37 · standard — Label ↗AP
2017-07-03Labeling · Supplement 36 · standard — Letter ↗AP
2016-03-17Manufacturing (CMC) · Supplement 35AP
2013-04-08Manufacturing (CMC) · Supplement 34AP
2006-01-31Labeling · Supplement 30 · standard — Label ↗AP
2002-10-25Manufacturing (CMC) · Supplement 29AP
2002-09-23Manufacturing (CMC) · Supplement 28AP
2002-03-21Manufacturing (CMC) · Supplement 27AP
2000-12-01Labeling · Supplement 24 · standardAP
2000-05-11Manufacturing (CMC) · Supplement 26AP
2000-03-30Manufacturing (CMC) · Supplement 25AP
1999-08-27Manufacturing (CMC) · Supplement 23AP
1997-11-14Labeling · Supplement 22 · standardAP
1997-05-23Manufacturing (CMC) · Supplement 21AP
1996-08-08Manufacturing (CMC) · Supplement 18AP
1996-05-29Labeling · Supplement 20 · standardAP
1996-05-08Labeling · Supplement 19 · standardAP
1995-07-20Manufacturing (CMC) · Supplement 17AP
1995-04-28Manufacturing (CMC) · Supplement 16AP
1995-01-20Labeling · Supplement 15 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 13AP
1994-09-13Manufacturing (CMC) · Supplement 14AP
1993-02-09Manufacturing (CMC) · Supplement 3AP
1993-01-15Manufacturing (CMC) · Supplement 10AP
1992-10-09Manufacturing (CMC) · Supplement 11AP
1992-09-30Manufacturing (CMC) · Supplement 12AP
1992-07-17Manufacturing (CMC) · Supplement 6AP
1992-06-19Manufacturing (CMC) · Supplement 7AP
1992-05-15Efficacy · Supplement 8AP
1990-07-24Labeling · Supplement 4AP
1990-01-11Labeling · Supplement 2AP
1989-06-23Type 1 - New Molecular Entity · Original · priorityAP
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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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