Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 100MG | 1 | CAPRELSA | VANDETANIB |
| 002 | TABLET;ORAL | 300MG | 1 | CAPRELSA | VANDETANIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2011-04-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2012-10-09 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-07-03 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2013-11-27 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-03-31 | STANDARD |
| REMS; REMS | SUPPL | 9 | AP | 2017-05-16 | N/A |
| LABELING; Labeling | SUPPL | 10 | AP | 2016-07-28 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2017-02-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2018-10-12 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2020-06-05 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2020-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2022-03-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 14 | Orphan | 5 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Orphan | 5 |
| SUPPL | 19 | Null | 15 |
CDER Filings
GENZYME CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 22405
[companyName] => GENZYME CORP
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/022405s017lbl.pdf#page=20"]
[products] => [{"drugName":"CAPRELSA","activeIngredients":"VANDETANIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"CAPRELSA","activeIngredients":"VANDETANIB","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/15\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022405s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022405s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022405s016lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022405s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2018","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022405s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022405s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022405s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022405s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/09\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022405s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/09\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022405s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022405s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022405s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CAPRELSA","submission":"VANDETANIB","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CAPRELSA","submission":"VANDETANIB","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-06-15
)
)