ANDA 077620

SUN PHARM INDS INC

FDA Drug Application

Application #077620

Application Sponsors

ANDA 077620

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	2.5MG;250MG	0	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	2.5MG;500MG	0	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	5MG;500MG	0	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-01-11
LABELING; Labeling	SUPPL	2	AP	2009-02-03
LABELING; Labeling	SUPPL	3	AP	2009-03-11
LABELING; Labeling	SUPPL	11	AP	2015-09-21	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-04-05	STANDARD

Submissions Property Types

SUPPL	11	Null	7
SUPPL	13	Null	7

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77620
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","strength":"2.5MG;250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","strength":"2.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","strength":"5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","submission":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","actionType":"2.5MG;250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","submission":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","actionType":"2.5MG;500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","submission":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","actionType":"5MG;500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)