ANDA 201808

WATSON LABS INC

FDA Drug Application

Application #201808

Application Sponsors

ANDA 201808

WATSON LABS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 0.5MG BASE	0	VARENICLINE TARTRATE	VARENICLINE TARTRATE
002	TABLET;ORAL	EQ 1MG BASE	0	VARENICLINE TARTRATE	VARENICLINE TARTRATE

FDA Submissions

N/A; Not Applicable

ORIG

1

TA

2016-12-15

Submissions Property Types

ORIG

1

Null

19

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201808
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VARENICLINE TARTRATE","activeIngredients":"VARENICLINE TARTRATE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VARENICLINE TARTRATE","activeIngredients":"VARENICLINE TARTRATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/15\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-15
        )

)