ANDA 200752

MYLAN INSTITUTIONAL

FDA Drug Application

Application #200752

Application Sponsors

ANDA 200752

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	0	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2011-10-19
LABELING; Labeling	SUPPL	2	AP	2015-05-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-05-19	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15
SUPPL	4	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200752
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXRAZOXANE HYDROCHLORIDE","activeIngredients":"DEXRAZOXANE HYDROCHLORIDE","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXRAZOXANE HYDROCHLORIDE","activeIngredients":"DEXRAZOXANE HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/19\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/19\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/19\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-05-19
        )

)