ANDA 090284

INVAGEN PHARMS

FDA Drug Application

Application #090284

Application Sponsors

ANDA 090284

INVAGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

10MG

0

ALFUZOSIN HYDROCHLORIDE

ALFUZOSIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2012-01-17
LABELING; Labeling	SUPPL	4	AP	2015-01-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-01-13	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90284
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALFUZOSIN HYDROCHLORIDE","activeIngredients":"ALFUZOSIN HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALFUZOSIN HYDROCHLORIDE","submission":"ALFUZOSIN HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)