ANDA 201950

APOTEX INC

FDA Drug Application

Application #201950

Application Sponsors

ANDA 201950

APOTEX INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 0.5MG BASE	0	RASAGILINE MESYLATE	RASAGILINE MESYLATE
002	TABLET;ORAL	EQ 1MG BASE	0	RASAGILINE MESYLATE	RASAGILINE MESYLATE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-09-12

Submissions Property Types

ORIG

1

Null

19

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201950
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RASAGILINE MESYLATE","activeIngredients":"RASAGILINE MESYLATE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RASAGILINE MESYLATE","activeIngredients":"RASAGILINE MESYLATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/12\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/17\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-17
        )

)