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FDA NDA · NDA020638

VISTIDE

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APPLICATION
NDA020638
TYPE
NDA
ORIGINAL APPROVAL
1996-06-26
LATEST ACTION
2013-11-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

VISTIDE · ReferenceDiscontinued
CIDOFOVIR EQ 375MG BASE/5ML (EQ 75MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2013-11-13Manufacturing (CMC) · Supplement 11 · standardAP
2001-06-26Manufacturing (CMC) · Supplement 4 · standardAP
1999-03-09Efficacy · Supplement 3 · standard — Label ↗AP
1996-11-14Labeling · Supplement 2 · standardAP
1996-06-26Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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