ANDA 091476

ANCHEN PHARMS

FDA Drug Application

Application #091476

Documents

• Letter: 2013-03-15

Application Sponsors

ANDA 091476

ANCHEN PHARMS

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

	ORIG	1	AP	2013-03-13
LABELING; Labeling	SUPPL	6	AP	2015-09-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91476
            [companyName] => ANCHEN PHARMS
            [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":"FLUVOXAMINE MALEATE","submission":"FLUVOXAMINE MALEATE","actionType":"100MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUVOXAMINE MALEATE","submission":"FLUVOXAMINE MALEATE","actionType":"150MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)