ANDA 078905

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078905

Application Sponsors

ANDA 078905

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 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	2011-01-31
LABELING; Labeling	SUPPL	2	AP	2015-06-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-04-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78905
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","strength":"2.5MG;250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","strength":"2.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","strength":"5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","submission":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","actionType":"2.5MG;250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","submission":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","actionType":"2.5MG;500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIPIZIDE AND METFORMIN HYDROCHLORIDE","submission":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","actionType":"5MG;500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)