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FDA NDA · NDA020068

FOSCAVIR

foscarnet sodium

Sponsor: CLINIGEN HLTHCARE

APPLICATION
NDA020068
TYPE
NDA
ORIGINAL APPROVAL
1991-09-27
LATEST ACTION
2020-10-28
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

FOSCAVIR · ReferencePrescription
FOSCARNET SODIUM 6GM/250ML (24MG/ML) · SOLUTION · INTRAVENOUS
FOSCAVIR · ReferenceDiscontinued
FOSCARNET SODIUM 12GM/500ML (24MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2020-10-28Manufacturing (CMC) · Supplement 25 — Letter ↗AP
2017-02-24Labeling · Supplement 23 · standard — Label ↗AP
2016-11-10Labeling · Supplement 22 · standard — Label ↗AP
2015-05-29Manufacturing (CMC) · Supplement 21AP
2014-11-07Labeling · Supplement 20 · standard — Label ↗AP
2014-06-10Manufacturing (CMC) · Supplement 19AP
2012-02-10Manufacturing (CMC) · Supplement 18 — Label ↗AP
2007-11-27Labeling · Supplement 17 · standard — Label ↗AP
2006-05-15Labeling · Supplement 16 · standard — Letter ↗AP
2000-06-13Labeling · Supplement 14 · standardAP
2000-06-13Labeling · Supplement 13 · standardAP
1998-11-16Manufacturing (CMC) · Supplement 12AP
1997-03-31Labeling · Supplement 9 · standardAP
1997-01-24Labeling · Supplement 8 · standardAP
1997-01-24Efficacy · Supplement 6 · standardAP
1997-01-24Efficacy · Supplement 7 · standardAP
1997-01-03Manufacturing (CMC) · Supplement 10AP
1995-12-12Labeling · Supplement 2AP
1995-11-17Labeling · Supplement 5 · standardAP
1995-06-16Efficacy · Supplement 3 · unknownAP
1991-09-27Type 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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