ANDA 076172

ACTAVIS LABS FL INC

FDA Drug Application

Application #076172

Application Sponsors

ANDA 076172

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

500MG

0

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-06-16
LABELING; Labeling	SUPPL	6	AP	2007-05-25
LABELING; Labeling	SUPPL	13	AP	2008-10-31
LABELING; Labeling	SUPPL	25	AP	2019-02-26	STANDARD
LABELING; Labeling	SUPPL	27	AP	2019-02-26	STANDARD

Submissions Property Types

SUPPL	25	Null	7
SUPPL	27	Null	15

TE Codes

001

Prescription

AB1

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76172
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)