ANDA 075292

NOSTRUM LABS INC

FDA Drug Application

Application #075292

Documents

• Letter: 2004-06-04
• Letter: 2003-04-10
• Other Important Information from FDA: 2005-08-01

Application Sponsors

ANDA 075292

NOSTRUM LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

EQ 20MG BASE/5ML

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-02-07
LABELING; Labeling	SUPPL	4	AP	2005-05-17
LABELING; Labeling	SUPPL	5	AP	2005-05-17
LABELING; Labeling	SUPPL	7	AP	2006-03-15
LABELING; Labeling	SUPPL	9	AP	2006-08-29
LABELING; Labeling	SUPPL	10	AP	2006-08-29
LABELING; Labeling	SUPPL	11	AP	2007-06-29
LABELING; Labeling	SUPPL	12	AP	2007-06-29
LABELING; Labeling	SUPPL	15	AP	2008-12-02
LABELING; Labeling	SUPPL	17	AP	2012-05-29
LABELING; Labeling	SUPPL	18	AP	2014-09-02	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-01-04	STANDARD
LABELING; Labeling	SUPPL	20	AP	2021-09-12	STANDARD
LABELING; Labeling	SUPPL	21	AP	2021-09-20	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	17	Null	15
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	7

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75292
            [companyName] => NOSTRUM LABS INC
            [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
        )

)