ANDA 077078

CADILA

FDA Drug Application

Application #077078

Application Sponsors

ANDA 077078

CADILA

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

750MG

0

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-04-21
LABELING; Labeling	SUPPL	2	AP	2008-01-28
LABELING; Labeling	SUPPL	3	AP	2008-10-31

TE Codes

001

Prescription

AB

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77078
            [companyName] => CADILA
            [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
        )

)