ANDA 090116

LANNETT CO INC

FDA Drug Application

Application #090116

Application Sponsors

ANDA 090116

LANNETT CO INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-04-14
LABELING; Labeling	SUPPL	2	AP	2011-09-30
LABELING; Labeling	SUPPL	3	AP	2012-02-10
LABELING; Labeling	SUPPL	4	AP	2013-08-08	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-01-16	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	8
SUPPL	5	Null	7

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90116
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ONDANSETRON HYDROCHLORIDE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)