ANDA 201899

ALKEM LABS LTD

FDA Drug Application

Application #201899

Application Sponsors

ANDA 201899

ALKEM LABS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 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

ORIG

1

TA

2015-05-21

Submissions Property Types

ORIG

1

Null

0

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201899
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RASAGILINE MESYLATE","activeIngredients":"RASAGILINE MESYLATE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RASAGILINE MESYLATE","activeIngredients":"RASAGILINE MESYLATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-05-21
        )

)