ANDA 076934

ACI HEALTHCARE LTD

FDA Drug Application

Application #076934

Documents

• Other Important Information from FDA: 2006-07-05
• Letter: 2006-07-03

Application Sponsors

ANDA 076934

ACI HEALTHCARE LTD

Marketing Status

• Discontinued: 001

Application Products

001

CONCENTRATE;ORAL

EQ 20MG BASE/ML

0

SERTRALINE HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-06-30
LABELING; Labeling	SUPPL	3	AP	2008-01-09
LABELING; Labeling	SUPPL	4	AP	2008-01-09
LABELING; Labeling	SUPPL	5	AP	2008-07-16
LABELING; Labeling	SUPPL	6	AP	2015-11-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-04-05	STANDARD

Submissions Property Types

SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AA

CDER Filings

ACI HEALTHCARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76934
            [companyName] => ACI HEALTHCARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 20MG BASE\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 20MG BASE\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)