ANDA 075690

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #075690

Documents

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

Application Sponsors

ANDA 075690

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

EQ 20MG BASE/5ML

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-01-31
LABELING; Labeling	SUPPL	8	AP	2021-09-20	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	15

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75690
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)