ANDA 078634

WATSON LABS TEVA

FDA Drug Application

Application #078634

Application Sponsors

ANDA 078634

WATSON LABS TEVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

BICALUTAMIDE

BICALUTAMIDE

FDA Submissions

	ORIG	1	AP	2009-08-28
LABELING; Labeling	SUPPL	4	AP	2016-05-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-05-10	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-02-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78634
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BICALUTAMIDE","activeIngredients":"BICALUTAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BICALUTAMIDE","submission":"BICALUTAMIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)