Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 200MG BASE | 1 | VOTRIENT | PAZOPANIB HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 400MG BASE | 1 | VOTRIENT | PAZOPANIB HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2009-10-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 2 | AP | 2010-04-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 3 | AP | 2011-10-21 | UNKNOWN |
| LABELING; Labeling | SUPPL | 5 | AP | 2011-10-21 | UNKNOWN |
| REMS; REMS | SUPPL | 6 | AP | 2011-04-21 | N/A |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2012-01-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2012-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2012-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2012-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2012-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2013-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2013-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2013-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2013-11-27 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2014-06-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2014-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2015-04-01 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2015-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2016-05-20 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2016-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2017-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2017-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2020-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2020-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2020-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2021-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2021-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2021-12-13 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 15 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 32 | Null | 7 |
CDER Filings
NOVARTIS
cder:Array
(
[0] => Array
(
[ApplNo] => 22465
[companyName] => NOVARTIS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/022465s031s032lbl.pdf#page=27"]
[products] => [{"drugName":"VOTRIENT","activeIngredients":"PAZOPANIB HYDROCHLORIDE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VOTRIENT","activeIngredients":"PAZOPANIB HYDROCHLORIDE","strength":"EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/13\/2021","submission":"SUPPL-33","supplementCategories":"Manufacturing (CMC)-Manufacturing Process","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022465Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2021","submission":"SUPPL-32","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022465s031s032lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2021","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022465s031s032lbl.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\\\/022465s031s032lbl.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\\\/022465s031s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2020","submission":"SUPPL-29","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022465s029lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2020","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022465s029lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2020","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022465s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2020","submission":"SUPPL-28","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022465s028lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2020","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022465s028lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022465s024s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022465s024s025lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022465s023lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2016","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022465s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2015","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022465s021lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022465s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022465s020lbledt.pdf\"}]","notes":""},{"actionDate":"11\/18\/2014","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022465s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022465s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022465s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2013","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022465s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022465s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022465s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022465s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022465s-010S-012lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2012","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022465s-010S-012lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022465s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2012","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022465s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022465s003s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022465s003s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2011","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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[originalApprovals] => [{"actionDate":"VOTRIENT","submission":"PAZOPANIB HYDROCHLORIDE","actionType":"EQ 200MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VOTRIENT","submission":"PAZOPANIB HYDROCHLORIDE","actionType":"EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-12-13
)
)