Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 200MG | 1 | XALKORI | CRIZOTINIB |
| 002 | CAPSULE;ORAL | 250MG | 1 | XALKORI | CRIZOTINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2011-08-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2012-02-17 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2012-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2013-03-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2013-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2013-09-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2013-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2014-02-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 2014-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2014-08-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 13 | AP | 2015-03-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2015-09-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2015-12-07 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2016-03-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 2016-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2016-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2017-04-28 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2017-01-24 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2017-07-21 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2018-02-07 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2018-02-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2018-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2018-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2019-06-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2021-01-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 31 | AP | 2021-09-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2022-07-14 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 14 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 14 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 14 |
| SUPPL | 11 | Orphan | 5 |
| SUPPL | 12 | Null | 14 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 14 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 33 | Null | 7 |
CDER Filings
PF PRISM CV
cder:Array
(
[0] => Array
(
[ApplNo] => 202570
[companyName] => PF PRISM CV
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/202570s033lbl.pdf#page=39"]
[products] => [{"drugName":"XALKORI","activeIngredients":"CRIZOTINIB","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XALKORI","activeIngredients":"CRIZOTINIB","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/14\/2022","submission":"SUPPL-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/202570s033lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2021","submission":"SUPPL-31","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202570s031lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2021","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202570s031lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2021","submission":"SUPPL-30","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202570s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2019","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202570s028lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2018","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202570s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2018","submission":"SUPPL-26","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202570s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202570s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202570s021lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2017","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202570s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202570s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202570s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202570s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2016","submission":"SUPPL-16","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202570s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2015","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202570s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202570s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202570s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2013","submission":"SUPPL-6","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202570s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202570s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202570s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202570s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202570s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202570s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202570s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/26\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202570s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202570Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202570Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202570Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"07\/14\/2022","submission":"SUPPL-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/202570s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/202570Orig1s033ltr.pdf\"}]","notes":">"},{"actionDate":"09\/22\/2021","submission":"SUPPL-31","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202570s031lbl.pdf\"}]","notes":">"},{"actionDate":"01\/14\/2021","submission":"SUPPL-30","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202570s030lbl.pdf\"},{\"name\":\"Letter 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202570s027ltr.pdf\"}]","notes":">"},{"actionDate":"11\/30\/2018","submission":"SUPPL-26","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202570s026lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202570s026ltr.pdf\"}]","notes":">"},{"actionDate":"02\/07\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202570Orig1s024ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/07\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202570s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202570Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"07\/21\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202570s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202570Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"01\/24\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202570s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202570Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2017","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202570s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202570Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202570s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202570Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"04\/29\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202570s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202570Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"03\/11\/2016","submission":"SUPPL-16","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202570s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202570Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"12\/07\/2015","submission":"SUPPL-15","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/14\/2015","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202570s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202570Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"03\/20\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202570s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202570Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"08\/26\/2014","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202570s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202570Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"02\/14\/2014","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/07\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202570s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202570Orig1s007,s009ltr.pdf\"}]","notes":">"},{"actionDate":"09\/13\/2013","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/07\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202570s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202570s007,s009ltr.pdf\"}]","notes":">"},{"actionDate":"11\/20\/2013","submission":"SUPPL-6","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202570s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202570Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"03\/12\/2013","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/28\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202570s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202570Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/24\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202570s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202570s003ltr.pdf\"}]","notes":">"},{"actionDate":"02\/17\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202570s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202570s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2022-07-14
)
)