ANDA 075888

UPSHER SMITH LABS

FDA Drug Application

Application #075888

Documents

• Letter: 2000-11-29
• Other Important Information from FDA: 2007-05-09

Application Sponsors

ANDA 075888

UPSHER SMITH LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 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	2000-11-29
LABELING; Labeling	SUPPL	4	AP	2003-01-22
LABELING; Labeling	SUPPL	11	AP	2004-06-10
LABELING; Labeling	SUPPL	12	AP	2004-09-30
LABELING; Labeling	SUPPL	14	AP	2005-04-20
LABELING; Labeling	SUPPL	16	AP	2005-05-03
LABELING; Labeling	SUPPL	19	AP	2006-07-24
LABELING; Labeling	SUPPL	21	AP	2007-06-27
LABELING; Labeling	SUPPL	23	AP	2007-09-14
LABELING; Labeling	SUPPL	24	AP	2009-06-11
LABELING; Labeling	SUPPL	26	AP	2013-01-09
LABELING; Labeling	SUPPL	32	AP	2015-07-29	STANDARD
LABELING; Labeling	SUPPL	36	AP	2015-07-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	26	Null	15
SUPPL	32	Null	15
SUPPL	36	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75888
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUVOXAMINE MALEATE","activeIngredients":"FLUVOXAMINE MALEATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUVOXAMINE MALEATE","activeIngredients":"FLUVOXAMINE MALEATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUVOXAMINE MALEATE","activeIngredients":"FLUVOXAMINE MALEATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUVOXAMINE MALEATE","submission":"FLUVOXAMINE MALEATE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUVOXAMINE MALEATE","submission":"FLUVOXAMINE MALEATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUVOXAMINE MALEATE","submission":"FLUVOXAMINE MALEATE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)