NDA 022138

SANOFI AVENTIS US

FDA Drug Application

Application #022138

Documents

• Letter: 2007-05-29
• Label: 2007-05-29
• Review: 2009-03-24
• Other Important Information from FDA: 2013-11-07

Application Sponsors

NDA 022138

SANOFI AVENTIS US

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

100MG/ML

0

LOVENOX

ENOXAPARIN SODIUM

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2007-05-16

PRIORITY

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22138
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOVENOX","activeIngredients":"ENOXAPARIN SODIUM","strength":"100MG\/ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/16\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022138,020164s075lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LOVENOX","submission":"ENOXAPARIN SODIUM","actionType":"100MG\/ML","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-05-16
        )

)