Vistide

NDA 20638, held by Gilead Sciences Inc. Cidofovir.

As of Nov 15, 2026, NDA 20638 (Vistide), held by Gilead Sciences Inc, was first approved by FDA on Jun 26, 1996, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 26, 1996
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


Mar 9, 1999	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label
Jun 26, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
VistideEQ 375MG BASE/5ML (EQ 75MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;intravenous	Cidofovir	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Nov 13, 2013	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 26, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 9, 1999	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label
Nov 14, 1996	Supplement 2Labeling · Standard review	Approved	None posted
Jun 26, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20638
Drugs@FDA: Overview at FDA
Company: Gilead Sciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters