ANDA 078980

MYLAN INSTITUTIONAL

FDA Drug Application

Application #078980

Application Sponsors

ANDA 078980

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	0	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	0	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-04-13
LABELING; Labeling	SUPPL	2	AP	2009-08-20

Submissions Property Types

SUPPL

2

Null

7

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78980
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MITOXANTRONE HYDROCHLORIDE","activeIngredients":"MITOXANTRONE HYDROCHLORIDE","strength":"EQ 20MG BASE\/10ML (EQ 2MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MITOXANTRONE HYDROCHLORIDE","activeIngredients":"MITOXANTRONE HYDROCHLORIDE","strength":"EQ 30MG BASE\/15ML (EQ 2MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MITOXANTRONE HYDROCHLORIDE","submission":"MITOXANTRONE HYDROCHLORIDE","actionType":"EQ 20MG BASE\/10ML (EQ 2MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MITOXANTRONE HYDROCHLORIDE","submission":"MITOXANTRONE HYDROCHLORIDE","actionType":"EQ 30MG BASE\/15ML (EQ 2MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)