ANDA 079158

LANNETT CO INC

FDA Drug Application

Application #079158

Application Sponsors

ANDA 079158

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

RISPERIDONE

RISPERIDONE

FDA Submissions

	ORIG	1	AP	2010-12-03
LABELING; Labeling	SUPPL	2	AP	2011-10-26
LABELING; Labeling	SUPPL	3	AP	2011-11-04
LABELING; Labeling	SUPPL	5	AP	2012-01-30
LABELING; Labeling	SUPPL	9	AP	2012-10-22	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-11-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79158
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"1MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)