Documents
Application Sponsors
| NDA 209482 | GLAXOSMITHKLINE | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INHALATION | 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 1 | TRELEGY ELLIPTA | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
| 002 | POWDER;INHALATION | 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 1 | TRELEGY ELLIPTA | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2017-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-05-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2020-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2020-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2022-05-11 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2022-12-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 31 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 16 | Null | 6 |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 209482
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/209482s000lbl.pdf#page=33"]
[products] => [{"drugName":"TRELEGY ELLIPTA","activeIngredients":"FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE","strength":"0.1MG\/INH;EQ 0.0625MG BASE\/INH;EQ 0.025MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/15\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209482s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209482s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2019","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209482s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2018","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209482s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209482s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/18\/2017","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\\\/2017\\\/209482s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209482Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209482Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/15\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209482s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209482Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/07\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209482s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209482Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"01\/07\/2019","submission":"SUPPL-2","supplementCategories":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209482s002lbl.pdf\"}]","notes":">"},{"actionDate":"04\/24\/2018","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209482s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209482Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-05-15
)
)