Documents
Application Sponsors
| BLA 125514 | MERCK SHARP DOHME | |
Marketing Status
Application Products
| 001 | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | 50MG | 2 | KEYTRUDA | PEMBROLIZUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-09-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-06-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2015-12-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2015-10-02 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2015-12-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2016-10-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2016-08-05 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2016-10-24 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2017-05-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2017-05-23 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2017-03-14 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2017-05-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2017-05-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2017-05-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 2017-07-27 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2017-07-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2017-09-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2018-06-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 31 | AP | 2017-11-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 34 | AP | 2018-06-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2018-08-20 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 2018-12-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 40 | AP | 2019-02-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 41 | AP | 2018-10-30 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 42 | AP | 2018-11-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 43 | AP | 2018-06-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 45 | AP | 2018-12-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 46 | AP | 2018-08-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 47 | AP | 2019-04-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 48 | AP | 2020-11-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 52 | AP | 2019-06-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 53 | AP | 2019-06-17 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 54 | AP | 2019-04-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 55 | AP | 2019-07-30 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 56 | AP | 2019-07-30 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 59 | AP | 2020-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 60 | AP | 2020-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 61 | AP | 2020-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 62 | AP | 2020-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 63 | AP | 2020-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 64 | AP | 2020-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 65 | AP | 2019-09-17 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 66 | AP | 2020-01-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 67 | AP | 2020-01-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 68 | AP | 2020-06-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 69 | AP | 2020-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 70 | AP | 2020-10-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 71 | AP | 2020-06-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 76 | AP | 2020-04-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 77 | AP | 2020-04-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 78 | AP | 2020-04-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 79 | AP | 2020-04-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 80 | AP | 2020-04-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 81 | AP | 2020-04-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 82 | AP | 2020-04-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 83 | AP | 2020-04-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 84 | AP | 2020-06-29 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 85 | AP | 2020-10-14 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 88 | AP | 2020-11-13 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 89 | AP | 2021-07-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 90 | AP | 2020-06-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 91 | AP | 2021-03-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 92 | AP | 2020-06-24 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 93 | AP | 2021-03-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 95 | AP | 2022-02-04 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 96 | AP | 2021-03-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 97 | AP | 2021-05-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 98 | AP | 2021-02-10 | N/A |
| EFFICACY; Efficacy | SUPPL | 100 | AP | 2021-07-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 102 | AP | 2021-08-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 104 | AP | 2021-08-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 105 | AP | 2021-07-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 106 | AP | 2021-03-30 | STANDARD |
| LABELING; Labeling | SUPPL | 108 | AP | 2021-06-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 110 | AP | 2022-03-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 112 | AP | 2021-12-03 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 113 | AP | 2021-11-17 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 114 | AP | 2021-07-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 117 | AP | 2021-08-31 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 118 | AP | 2021-08-31 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 120 | AP | 2021-12-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 121 | AP | 2021-10-13 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 122 | AP | 2021-10-13 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 123 | AP | 2022-05-20 | STANDARD |
| LABELING; Labeling | SUPPL | 125 | AP | 2022-02-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 127 | AP | 2022-12-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 128 | AP | 2023-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 131 | AP | 2022-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 133 | AP | 2022-08-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 30 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 30 | Null | 15 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 41 | Null | 7 |
| SUPPL | 42 | Null | 15 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 6 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 48 | Null | 7 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 54 | Null | 7 |
| SUPPL | 55 | Null | 15 |
| SUPPL | 56 | Null | 6 |
| SUPPL | 59 | Null | 7 |
| SUPPL | 60 | Null | 15 |
| SUPPL | 61 | Null | 6 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 63 | Null | 6 |
| SUPPL | 64 | Null | 7 |
| SUPPL | 65 | Null | 30 |
| SUPPL | 66 | Null | 6 |
| SUPPL | 67 | Null | 6 |
| SUPPL | 68 | Null | 6 |
| SUPPL | 69 | Null | 15 |
| SUPPL | 70 | Null | 7 |
| SUPPL | 71 | Null | 15 |
| SUPPL | 76 | Null | 6 |
| SUPPL | 77 | Null | 7 |
| SUPPL | 78 | Null | 7 |
| SUPPL | 79 | Null | 15 |
| SUPPL | 80 | Null | 6 |
| SUPPL | 81 | Null | 6 |
| SUPPL | 82 | Null | 7 |
| SUPPL | 83 | Null | 7 |
| SUPPL | 84 | Null | 15 |
| SUPPL | 85 | Null | 30 |
| SUPPL | 88 | Null | 7 |
| SUPPL | 89 | Null | 6 |
| SUPPL | 90 | Null | 7 |
| SUPPL | 91 | Null | 6 |
| SUPPL | 92 | Null | 7 |
| SUPPL | 93 | Null | 7 |
| SUPPL | 95 | Null | 15 |
| SUPPL | 96 | Null | 15 |
| SUPPL | 97 | Null | 6 |
| SUPPL | 100 | Null | 15 |
| SUPPL | 102 | Null | 10 |
| SUPPL | 104 | Null | 7 |
| SUPPL | 105 | Null | 7 |
| SUPPL | 106 | Orphan | 5 |
| SUPPL | 108 | Null | 15 |
| SUPPL | 110 | Null | 15 |
| SUPPL | 112 | Null | 6 |
| SUPPL | 113 | Null | 15 |
| SUPPL | 114 | Null | 6 |
| SUPPL | 117 | Null | 7 |
| SUPPL | 118 | Null | 15 |
| SUPPL | 120 | Null | 6 |
| SUPPL | 121 | Null | 7 |
| SUPPL | 122 | Null | 7 |
| SUPPL | 123 | Null | 7 |
| SUPPL | 125 | Null | 15 |
| SUPPL | 127 | Null | 6 |
| SUPPL | 128 | Null | 6 |
| SUPPL | 131 | Null | 7 |
| SUPPL | 133 | Null | 7 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 125514
[companyName] => MERCK SHARP DOHME
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125514s084lbl.pdf#page=89"]
[products] => [{"drugName":"KEYTRUDA","activeIngredients":"PEMBROLIZUMAB","strength":"50MG","dosageForm":"POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"06\/29\/2020","submission":"SUPPL-84","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s084lbl.pdf\"}]","notes":""},{"actionDate":"06\/24\/2020","submission":"SUPPL-92","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s092lbl.pdf\"}]","notes":""},{"actionDate":"06\/24\/2020","submission":"SUPPL-68","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s068lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2020","submission":"SUPPL-90","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s071s090lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2020","submission":"SUPPL-71","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s071s090lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2020","submission":"SUPPL-83","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s059s064s076s083lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2020","submission":"SUPPL-67","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s067lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2020","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s067lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2020","submission":"SUPPL-66","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s066lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2019","submission":"SUPPL-65","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s065lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2019","submission":"SUPPL-56","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s055s056lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2019","submission":"SUPPL-55","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s055s056lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2019","submission":"SUPPL-53","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s053lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2019","submission":"SUPPL-52","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s052lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2019","submission":"SUPPL-54","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514Orig1s054lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2019","submission":"SUPPL-47","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s047lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2019","submission":"SUPPL-40","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s040lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2018","submission":"SUPPL-37","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s037lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2018","submission":"SUPPL-45","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s045lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2018","submission":"SUPPL-42","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s042lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2018","submission":"SUPPL-41","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s041lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2018","submission":"SUPPL-35","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s035lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2018","submission":"SUPPL-46","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s046lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2018","submission":"SUPPL-43","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s043lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2018","submission":"SUPPL-30","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2018","submission":"SUPPL-34","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s034lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2017","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s031lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2017","submission":"SUPPL-24","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s019s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s019s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s019s023lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2017","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2017","submission":"SUPPL-18","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s017s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2017","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s017s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2017","submission":"SUPPL-13","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2017","submission":"SUPPL-16","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2017","submission":"SUPPL-15","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2016","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125514s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2016","submission":"SUPPL-8","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125514s008s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2016","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125514s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2015","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125514s004s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2015","submission":"SUPPL-4","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125514s004s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2015","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125514s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125514s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125514s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125514lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/04\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125514lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125514Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125514Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125514Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/24\/2020","submission":"SUPPL-92","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s092lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s092ltr.pdf\"}]","notes":">"},{"actionDate":"06\/16\/2020","submission":"SUPPL-90","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s071s090lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s071,s090ltr.pdf\"}]","notes":">"},{"actionDate":"06\/29\/2020","submission":"SUPPL-84","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s084lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s084ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2020","submission":"SUPPL-83","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s059s064s076s083lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2020","submission":"SUPPL-82","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-81","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-80","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-79","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-78","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-77","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-76","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/16\/2020","submission":"SUPPL-71","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s071s090lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s071,s090ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2020","submission":"SUPPL-69","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/24\/2020","submission":"SUPPL-68","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s068lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s068ltr.pdf\"}]","notes":">"},{"actionDate":"01\/09\/2020","submission":"SUPPL-67","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s067lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s067ltr.pdf\"}]","notes":">"},{"actionDate":"01\/08\/2020","submission":"SUPPL-66","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125514s066lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s066ltr.pdf\"}]","notes":">"},{"actionDate":"09\/17\/2019","submission":"SUPPL-65","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s065lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125514Orig1s065ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2020","submission":"SUPPL-64","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-63","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-62","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-61","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-60","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2020","submission":"SUPPL-59","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/30\/2019","submission":"SUPPL-56","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s055s056lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125514Orig1s055,s056ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2019","submission":"SUPPL-55","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s055s056lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125514Orig1s055,s056ltr.pdf\"}]","notes":">"},{"actionDate":"04\/19\/2019","submission":"SUPPL-54","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514Orig1s054lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125514Orig1s054ltr.pdf\"}]","notes":">"},{"actionDate":"06\/17\/2019","submission":"SUPPL-53","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s053lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125514Orig1s053ltr.pdf\"}]","notes":">"},{"actionDate":"06\/10\/2019","submission":"SUPPL-52","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s052lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125514Orig1s052ltr.pdf\"}]","notes":">"},{"actionDate":"04\/11\/2019","submission":"SUPPL-47","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s047lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125514Orig1s047ltr.pdf\"}]","notes":">"},{"actionDate":"08\/16\/2018","submission":"SUPPL-46","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s046lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125514Orig1s046Ltr.pdf\"}]","notes":">"},{"actionDate":"12\/19\/2018","submission":"SUPPL-45","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s045lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125514Orig1s045Ltr.pdf\"}]","notes":">"},{"actionDate":"06\/19\/2018","submission":"SUPPL-43","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s043lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125514Orig1s043ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2018","submission":"SUPPL-42","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s042lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125514Orig1s042ltr.pdf\"}]","notes":">"},{"actionDate":"10\/30\/2018","submission":"SUPPL-41","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s041lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125514Orig1s041ltr.pdf\"}]","notes":">"},{"actionDate":"02\/15\/2019","submission":"SUPPL-40","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125514s040lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125514Orig1s040ltr.pdf\"}]","notes":">"},{"actionDate":"12\/28\/2018","submission":"SUPPL-37","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s037lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125514Orig1s037ltr.pdf\"}]","notes":">"},{"actionDate":"08\/20\/2018","submission":"SUPPL-35","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s035lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125514Orig1s035ltr.pdf\"}]","notes":">"},{"actionDate":"06\/12\/2018","submission":"SUPPL-34","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s034lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125514Orig1s034ltr.pdf\"}]","notes":">"},{"actionDate":"11\/29\/2017","submission":"SUPPL-31","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s031lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s031ltr.pdf\"}]","notes":">"},{"actionDate":"06\/13\/2018","submission":"SUPPL-30","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125514s030lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125514Orig1s030ltr.pdf\"}]","notes":">"},{"actionDate":"09\/22\/2017","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s024ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/125514Orig1s024TOC.cfm\"}]","notes":">"},{"actionDate":"07\/27\/2017","submission":"SUPPL-23","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s019s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s019s023ltr.pdf\"}]","notes":">"},{"actionDate":"07\/27\/2017","submission":"SUPPL-19","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s019s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s019s023ltr.pdf\"}]","notes":">"},{"actionDate":"05\/18\/2017","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s017s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"05\/18\/2017","submission":"SUPPL-17","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s017s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"05\/10\/2017","submission":"SUPPL-16","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"03\/14\/2017","submission":"SUPPL-15","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"05\/23\/2017","submission":"SUPPL-14","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s014ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/125514Orig1s014.pdf\"}]","notes":">"},{"actionDate":"05\/17\/2017","submission":"SUPPL-13","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125514s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125514Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"10\/24\/2016","submission":"SUPPL-12","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125514s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125514Orig1s008,125514Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"08\/05\/2016","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125514s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125514Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/24\/2016","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125514s008s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125514Orig1s008,125514Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"12\/18\/2015","submission":"SUPPL-6","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125514s004s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125514Orig1s004s006ltr.pdf\"}]","notes":">"},{"actionDate":"10\/02\/2015","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125514s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125514Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"12\/18\/2015","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125514s004s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125514Orig1s004s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/19\/2015","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125514s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125514Orig1s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-06-29
)
)