ANDA 078143

CELLTRION

FDA Drug Application

Application #078143

Documents

• Other Important Information from FDA: 2008-01-30

Application Sponsors

ANDA 078143

CELLTRION

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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	2008-01-16
LABELING; Labeling	SUPPL	2	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-02-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-02-09	STANDARD

Submissions Property Types

SUPPL	1	Null	8
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15

CDER Filings

CELLTRION

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78143
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)