ANDA 078582

ACI HEALTHCARE LTD

FDA Drug Application

Application #078582

Documents

• Letter: 2009-01-21
• Other Important Information from FDA: 2009-02-04

Application Sponsors

ANDA 078582

ACI HEALTHCARE LTD

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2009-01-15
LABELING; Labeling	SUPPL	2	AP	2009-09-15
LABELING; Labeling	SUPPL	3	AP	2010-09-21
REMS; REMS	SUPPL	4	AP	2011-11-17
LABELING; Labeling	SUPPL	5	AP	2014-12-09
LABELING; Labeling	SUPPL	6	AP	2013-02-27	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-12-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-12-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-05-18	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7

TE Codes

001

Prescription

AA

CDER Filings

ACI HEALTHCARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78582
            [companyName] => ACI HEALTHCARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"100MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"100MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)