NDA 020638

GILEAD SCIENCES INC

FDA Drug Application

Application #020638

Documents

• Label: 2005-01-28
• Review: 2019-02-15

Application Sponsors

NDA 020638

GILEAD SCIENCES INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

VISTIDE

CIDOFOVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-06-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	1996-11-14	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1999-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2013-11-13	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	11	Null	0

CDER Filings

GILEAD SCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20638
            [companyName] => GILEAD SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VISTIDE","activeIngredients":"CIDOFOVIR","strength":"EQ 75MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/09\/1999","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/020638s003lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VISTIDE","submission":"CIDOFOVIR","actionType":"EQ 75MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1999-03-09
        )

)