ANDA 077064

ZYDUS PHARMS USA

FDA Drug Application

Application #077064

Application Sponsors

ANDA 077064

ZYDUS PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	500MG	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	850MG	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	1GM	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-04-18
LABELING; Labeling	SUPPL	8	AP	2010-04-12
LABELING; Labeling	SUPPL	9	AP	2008-01-28
LABELING; Labeling	SUPPL	12	AP	2009-08-11
LABELING; Labeling	SUPPL	15	AP	2011-05-19
LABELING; Labeling	SUPPL	16	AP	2009-12-28
LABELING; Labeling	SUPPL	26	AP	2015-04-13	STANDARD

Submissions Property Types

SUPPL	8	Null	7
SUPPL	12	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	26	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77064
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"850MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"850MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)