ANDA 040153

INVATECH

FDA Drug Application

Application #040153

Application Sponsors

ANDA 040153

INVATECH

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	EQ 1MG BASE	0	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 2MG BASE	0	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE
003	TABLET;ORAL	EQ 5MG BASE	0	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE
004	TABLET;ORAL	EQ 10MG BASE	0	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1996-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-09-04
LABELING; Labeling	SUPPL	3	AP	2008-09-03

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

ATHEM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40153
            [companyName] => ATHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIFLUOPERAZINE HYDROCHLORIDE","activeIngredients":"TRIFLUOPERAZINE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRIFLUOPERAZINE HYDROCHLORIDE","activeIngredients":"TRIFLUOPERAZINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRIFLUOPERAZINE HYDROCHLORIDE","activeIngredients":"TRIFLUOPERAZINE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRIFLUOPERAZINE HYDROCHLORIDE","activeIngredients":"TRIFLUOPERAZINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIFLUOPERAZINE HYDROCHLORIDE","submission":"TRIFLUOPERAZINE HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRIFLUOPERAZINE HYDROCHLORIDE","submission":"TRIFLUOPERAZINE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRIFLUOPERAZINE HYDROCHLORIDE","submission":"TRIFLUOPERAZINE HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRIFLUOPERAZINE HYDROCHLORIDE","submission":"TRIFLUOPERAZINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)