ANDA 078042

ACI HEALTHCARE LTD

FDA Drug Application

Application #078042

Application Sponsors

ANDA 078042

ACI HEALTHCARE LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	250MG	0	LEVETIRACETAM	LEVETIRACETAM
002	TABLET;ORAL	500MG	0	LEVETIRACETAM	LEVETIRACETAM
003	TABLET;ORAL	750MG	0	LEVETIRACETAM	LEVETIRACETAM
004	TABLET;ORAL	1GM	0	LEVETIRACETAM	LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2009-01-15
LABELING; Labeling	SUPPL	2	AP	2010-02-26
LABELING; Labeling	SUPPL	4	AP	2010-02-26
LABELING; Labeling	SUPPL	5	AP	2010-04-22
LABELING; Labeling	SUPPL	6	AP	2010-11-23
LABELING; Labeling	SUPPL	7	AP	2010-11-22
REMS; REMS	SUPPL	8	AP	2011-11-17
LABELING; Labeling	SUPPL	9	AP	2013-02-28	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	4	Null	8
SUPPL	6	Null	8
SUPPL	8	Null	15
SUPPL	9	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ACI HEALTHCARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78042
            [companyName] => ACI HEALTHCARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)