ANDA 075899

SYNTHON PHARMS

FDA Drug Application

Application #075899

Documents

• Letter: 2001-01-17
• Other Important Information from FDA: 2007-05-09

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
        )

)