ANDA 079013

APOTEX INC

FDA Drug Application

Application #079013

Documents

• Letter: 2011-07-20

Application Sponsors

ANDA 079013

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

10MG

0

ALFUZOSIN HYDROCHLORIDE

ALFUZOSIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-07-18
LABELING; Labeling	SUPPL	3	AP	2015-01-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-01-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2018-12-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-09-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79013
            [companyName] => APOTEX INC
            [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
        )

)