ANDA 201962

APOTEX INC

FDA Drug Application

Application #201962

Application Sponsors

ANDA 201962

APOTEX 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

N/A; Not Applicable

ORIG

1

TA

2012-05-15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201962
            [companyName] => APOTEX 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":"06\/02\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-02
        )

)