NDA 209195

GILEAD SCIENCES INC

FDA Drug Application

Application #209195

Documents

• Label: 2017-07-19
• Letter: 2017-07-21
• Review: 2017-09-01
• Letter: 2017-11-13
• Label: 2017-11-13
• Letter: 2019-09-30
• Label: 2019-10-02
• Letter: 2019-11-19
• Label: 2019-11-19

Application Sponsors

NDA 209195

GILEAD SCIENCES INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

400MG;100MG;100MG

1

VOSEVI

SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2017-07-18	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2017-11-09	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-09-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	7

CDER Filings

GILEAD SCIENCES INC

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(
    [0] => Array
        (
            [ApplNo] => 209195
            [companyName] => GILEAD SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VOSEVI","activeIngredients":"SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR","strength":"400MG;100MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209195s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209195s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209195s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209195s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209195s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209195Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209195_toc.cfm\"}]","notes":">"}]
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            [actionDate] => 2019-11-15
        )

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