NDA 203093

GILEAD SCIENCES INC

FDA Drug Application

Application #203093

Documents

• Letter: 2014-09-26
• Letter: 2015-07-28
• Label: 2014-09-26
• Label: 2015-07-30
• Review: 2016-03-28

Application Sponsors

NDA 203093

GILEAD SCIENCES INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	85MG	1	VITEKTA	ELVITEGRAVIR
002	TABLET;ORAL	150MG	1	VITEKTA	ELVITEGRAVIR

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2015-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2016-01-21	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	0

CDER Filings

GILEAD SCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203093
            [companyName] => GILEAD SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VITEKTA","activeIngredients":"ELVITEGRAVIR","strength":"85MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VITEKTA","activeIngredients":"ELVITEGRAVIR","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/27\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203093s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203093s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203093s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/24\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203093s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203093Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/203093Orig1VITEKTAtoc.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/21\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/27\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203093s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203093Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"07\/16\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-01-21
        )

)