ANDA 090270

MYLAN INSTITUTIONAL

FDA Drug Application

Application #090270

Documents

• Letter: 2009-06-16

Application Sponsors

ANDA 090270

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG BASE/VIAL

0

MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-06-09
LABELING; Labeling	SUPPL	5	AP	2011-07-14
LABELING; Labeling	SUPPL	7	AP	2015-08-27

Submissions Property Types

ORIG	1	Null	1
SUPPL	5	Null	8
SUPPL	7	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90270
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELPHALAN HYDROCHLORIDE","activeIngredients":"MELPHALAN HYDROCHLORIDE","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MELPHALAN HYDROCHLORIDE","submission":"MELPHALAN HYDROCHLORIDE","actionType":"EQ 50MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)