Documents
Application Sponsors
ANDA 075899 | SYNTHON PHARMS | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Application Products
001 | TABLET;ORAL | 25MG | 0 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE |
002 | TABLET;ORAL | 50MG | 0 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE |
003 | TABLET;ORAL | 100MG | 0 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE |
FDA Submissions
| ORIG | 1 | AP | 2001-01-17 | |
LABELING; Labeling | SUPPL | 2 | AP | 2002-07-24 | |
LABELING; Labeling | SUPPL | 3 | AP | 2003-09-25 | |
LABELING; Labeling | SUPPL | 4 | AP | 2004-11-20 | |
LABELING; Labeling | SUPPL | 5 | AP | 2005-04-14 | |
LABELING; Labeling | SUPPL | 6 | AP | 2005-04-14 | |
LABELING; Labeling | SUPPL | 7 | AP | 2005-07-08 | |
LABELING; Labeling | SUPPL | 8 | AP | 2006-10-18 | |
LABELING; Labeling | SUPPL | 9 | AP | 2007-06-29 | |
LABELING; Labeling | SUPPL | 10 | AP | 2007-10-16 | |
CDER Filings
SYNTHON PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 75899
[companyName] => SYNTHON PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"FLUVOXAMINE MALEATE","activeIngredients":"FLUVOXAMINE MALEATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUVOXAMINE MALEATE","activeIngredients":"FLUVOXAMINE MALEATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUVOXAMINE MALEATE","activeIngredients":"FLUVOXAMINE MALEATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FLUVOXAMINE MALEATE","submission":"FLUVOXAMINE MALEATE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUVOXAMINE MALEATE","submission":"FLUVOXAMINE MALEATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUVOXAMINE MALEATE","submission":"FLUVOXAMINE MALEATE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)