NDA 010423

ROCHE

FDA Drug Application

Application #010423

Application Sponsors

NDA 010423

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

LORFAN

LEVALLORPHAN TARTRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1956-04-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2001-09-17
LABELING; Labeling	SUPPL	8	AP	1983-05-11
LABELING; Labeling	SUPPL	9	AP	1983-04-19

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10423
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORFAN","activeIngredients":"LEVALLORPHAN TARTRATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORFAN","submission":"LEVALLORPHAN TARTRATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)