NDA 212477

GILEAD SCIENCES INC

FDA Drug Application

Application #212477

Documents

• Label: 2019-08-29
• Letter: 2019-08-29
• Letter: 2019-09-20
• Label: 2019-09-20
• Letter: 2019-11-19
• Label: 2019-11-19
• Letter: 2019-12-05
• Label: 2020-03-06
• Letter: 2020-03-09
• Review: 2020-04-27

Application Sponsors

NDA 212477

GILEAD SCIENCES INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	PELLETS;ORAL	33.75MG;150MG/PACKET	1	HARVONI	LEDIPASVIR; SOFOSBUVIR
002	PELLETS;ORAL	45MG;200MG/PACKET	1	HARVONI	LEDIPASVIR; SOFOSBUVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-08-28	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-03-05	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-12-04	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7
SUPPL	3	Orphan	5
SUPPL	4	Null	15

CDER Filings

GILEAD SCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212477
            [companyName] => GILEAD SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HARVONI","activeIngredients":"LEDIPASVIR; SOFOSBUVIR","strength":"33.75MG;150MG\/PACKET","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"HARVONI","activeIngredients":"LEDIPASVIR; SOFOSBUVIR","strength":"45MG;200MG\/PACKET","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205834s032,212477s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205834s032,212477s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205834s028,212477s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205834s031,212477s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212477s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212477s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212477Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212477Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212477Orig1s004ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/05\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205834s032,212477s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/15\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205834s028,212477s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"09\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205834s031,212477s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205834Orig1s031,%20212477Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-03-05
        )

)