NDA 019879

SANOFI AVENTIS US

FDA Drug Application

Application #019879

Application Sponsors

NDA 019879

SANOFI AVENTIS US

Marketing Status

• Discontinued: 002

Application Products

002

INJECTABLE;INJECTION

200MG/ML

0

ORNIDYL

EFLORNITHINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-11-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-01-03	PRIORITY

Submissions Property Types

ORIG	1	Null	11
SUPPL	2	Null	14

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19879
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORNIDYL","activeIngredients":"EFLORNITHINE HYDROCHLORIDE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ORNIDYL","submission":"EFLORNITHINE HYDROCHLORIDE","actionType":"200MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)