Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LUVOX CR | FLUVOXAMINE MALEATE |
| 002 | CAPSULE, EXTENDED RELEASE;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LUVOX CR | FLUVOXAMINE MALEATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2008-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2009-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2011-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2011-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2011-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2012-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2014-07-18 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 11 | AP | 2017-01-04 | 901 REQUIRED |
Submissions Property Types
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 6 |
CDER Filings
JAZZ PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 22033
[companyName] => JAZZ PHARMS
[docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/022033s011lbl.pdf#page=26"]
[products] => [{"drugName":"LUVOX CR","activeIngredients":"FLUVOXAMINE MALEATE","strength":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"LUVOX CR","activeIngredients":"FLUVOXAMINE MALEATE","strength":"150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"01\/04\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022033s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022033s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022033s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022033s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2011","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022033s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2011","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022033s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2011","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022033s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022033s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022033lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LUVOX CR","submission":"FLUVOXAMINE MALEATE","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"LUVOX CR","submission":"FLUVOXAMINE MALEATE","actionType":"150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-01-04
)
)