ANDA 075920

SPECGX LLC

FDA Drug Application

Application #075920

Documents

• Other Important Information from FDA: 2005-08-01

Application Sponsors

ANDA 075920

SPECGX LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 20MG BASE/5ML

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-01-29
LABELING; Labeling	SUPPL	2	AP	2004-12-06
LABELING; Labeling	SUPPL	4	AP	2004-12-06
LABELING; Labeling	SUPPL	6	AP	2005-10-21
LABELING; Labeling	SUPPL	7	AP	2006-02-28
LABELING; Labeling	SUPPL	8	AP	2006-02-28
LABELING; Labeling	SUPPL	9	AP	2006-09-27
LABELING; Labeling	SUPPL	10	AP	2007-06-29
LABELING; Labeling	SUPPL	11	AP	2007-06-29
LABELING; Labeling	SUPPL	12	AP	2008-03-03
LABELING; Labeling	SUPPL	13	AP	2008-09-24
LABELING; Labeling	SUPPL	14	AP	2009-09-28
LABELING; Labeling	SUPPL	15	AP	2014-07-17	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-01-04	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-08-30	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-09-21	STANDARD

Submissions Property Types

SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	7

TE Codes

001

Prescription

AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75920
            [companyName] => SPECGX LLC
            [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
        )

)