ANDA 076881

ACI HEALTHCARE LTD

FDA Drug Application

Application #076881

Documents

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

Application Sponsors

ANDA 076881

ACI HEALTHCARE LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 25MG BASE	0	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 50MG BASE	0	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
003	TABLET;ORAL	EQ 100MG BASE	0	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-02-06
LABELING; Labeling	SUPPL	3	AP	2015-06-30
LABELING; Labeling	SUPPL	4	AP	2008-01-02
LABELING; Labeling	SUPPL	5	AP	2008-07-14
LABELING; Labeling	SUPPL	6	AP	2015-06-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-01-13	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ACI HEALTHCARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76881
            [companyName] => ACI HEALTHCARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)