ANDA 090221

WOCKHARDT LTD

FDA Drug Application

Application #090221

Application Sponsors

ANDA 090221

WOCKHARDT LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

10MG

0

ALFUZOSIN HYDROCHLORIDE

ALFUZOSIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2012-08-10
LABELING; Labeling	SUPPL	2	AP	2016-09-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

WOCKHARDT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90221
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALFUZOSIN HYDROCHLORIDE","activeIngredients":"ALFUZOSIN HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALFUZOSIN HYDROCHLORIDE","submission":"ALFUZOSIN HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)