ANDA 076038

SUN PHARM INDUSTRIES

FDA Drug Application

Application #076038

Documents

• Letter: 2003-04-10

Application Sponsors

ANDA 076038

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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	2002-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-12-12
LABELING; Labeling	SUPPL	4	AP	2002-08-13
LABELING; Labeling	SUPPL	18	AP	2005-04-20
LABELING; Labeling	SUPPL	24	AP	2007-03-16
LABELING; Labeling	SUPPL	29	AP	2008-11-13

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76038
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"850MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"850MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)