NDA 205625

GLAXOSMITHKLINE

FDA Drug Application

Application #205625

Documents

• Letter: 2014-08-21
• Letter: 2015-03-24
• Label: 2014-08-22
• Label: 2015-03-24
• Review: 2015-10-07
• Summary Review: 2015-10-07
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Label: 2018-05-21
• Letter: 2018-05-21
• Label: 2019-01-08
• Letter: 2019-02-13

Application Sponsors

NDA 205625

GLAXOSMITHKLINE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	POWDER;INHALATION	0.1MG/INH	1	ARNUITY ELLIPTA	FLUTICASONE FUROATE
002	POWDER;INHALATION	0.2MG/INH	1	ARNUITY ELLIPTA	FLUTICASONE FUROATE
003	POWDER;INHALATION	0.05MG/INH	1	ARNUITY ELLIPTA	FLUTICASONE FUROATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2014-08-20	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2018-05-17	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-01-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	31

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205625
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARNUITY ELLIPTA","activeIngredients":"FLUTICASONE FUROATE","strength":"0.1MG\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ARNUITY ELLIPTA","activeIngredients":"FLUTICASONE FUROATE","strength":"0.2MG\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ARNUITY ELLIPTA","activeIngredients":"FLUTICASONE FUROATE","strength":"0.05MG\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/07\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205625s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205625s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205625Orig1s001Lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205625s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/20\/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\\\/205625s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205625Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205625Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205625Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/07\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205625s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205625Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"05\/17\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205625s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205625Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"03\/20\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205625Orig1s001Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205625Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-01-07
        )

)