ANDA 090461

TRIS PHARMA INC

FDA Drug Application

Application #090461

Application Sponsors

ANDA 090461

TRIS PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2010-09-30
LABELING; Labeling	SUPPL	2	AP	2015-09-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-09-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AA

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90461
            [companyName] => TRIS PHARMA INC
            [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
        )

)