ANDA 076869

ACTAVIS LABS FL INC

FDA Drug Application

Application #076869

Application Sponsors

ANDA 076869

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

750MG

0

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-04-12
LABELING; Labeling	SUPPL	4	AP	2007-05-25
LABELING; Labeling	SUPPL	11	AP	2008-10-31
LABELING; Labeling	SUPPL	24	AP	2019-02-26	STANDARD
LABELING; Labeling	SUPPL	26	AP	2019-02-26	STANDARD

Submissions Property Types

SUPPL	24	Null	15
SUPPL	26	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76869
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)