ANDA 075465

MARKSANS PHARMA

FDA Drug Application

Application #075465

Documents

• Letter: 2004-06-04
• Letter: 2004-06-04
• Label: 2004-06-04
• Review: 2003-08-04
• Other Important Information from FDA: 2005-08-01

Application Sponsors

ANDA 075465

MARKSANS PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	EQ 10MG BASE	0	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 20MG BASE	0	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 40MG BASE	0	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-01-29
LABELING; Labeling	SUPPL	8	AP	2005-06-07
LABELING; Labeling	SUPPL	10	AP	2006-03-02
LABELING; Labeling	SUPPL	11	AP	2006-11-17
LABELING; Labeling	SUPPL	12	AP	2006-11-17
LABELING; Labeling	SUPPL	13	AP	2008-04-24
LABELING; Labeling	SUPPL	14	AP	2008-12-15
LABELING; Labeling	SUPPL	15	AP	2009-08-21
LABELING; Labeling	SUPPL	16	AP	2009-08-21
LABELING; Labeling	SUPPL	17	AP	2011-11-22
LABELING; Labeling	SUPPL	18	AP	2012-04-19
LABELING; Labeling	SUPPL	19	AP	2014-10-21	STANDARD

Submissions Property Types

SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	7

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB

CDER Filings

MARKSANS PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75465
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/29\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2002\\\/75465_Fluoxetine_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-01-29
        )

)