ANDA 200835

WATSON LABS INC

FDA Drug Application

Application #200835

Application Sponsors

ANDA 200835

WATSON LABS INC

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE; ORAL	174MG	0	BUPROPION HYDROBROMIDE	BUPROPION HYDROBROMIDE
002	TABLET, EXTENDED RELEASE; ORAL	522MG	0	BUPROPION HYDROBROMIDE	BUPROPION HYDROBROMIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

TA

2013-08-13

Submissions Property Types

ORIG

1

Null

19

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200835
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROBROMIDE","activeIngredients":"BUPROPION HYDROBROMIDE","strength":"174MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROBROMIDE","activeIngredients":"BUPROPION HYDROBROMIDE","strength":"522MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/13\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-08-13
        )

)