Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | 0 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE |
002 | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | 0 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2014-10-31 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 203240
[companyName] => TORRENT
[docInserts] => ["",""]
[products] => [{"drugName":"FLUVOXAMINE MALEATE","activeIngredients":"FLUVOXAMINE MALEATE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUVOXAMINE MALEATE","activeIngredients":"FLUVOXAMINE MALEATE","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/31\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2014-10-31
)
)