ANDA 202019

MYLAN PHARMS INC

FDA Drug Application

Application #202019

Application Sponsors

ANDA 202019

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET; ORAL	0.5MG	0	VARENICLINE	VARENICLINE
002	TABLET; ORAL	1MG	0	VARENICLINE	VARENICLINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2013-05-03

Submissions Property Types

ORIG

1

Null

17

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202019
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VARENICLINE","activeIngredients":"VARENICLINE","strength":"0.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VARENICLINE","activeIngredients":"VARENICLINE","strength":"1MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/03\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-05-03
        )

)