ANDA 078321

CSPC OUYI

FDA Drug Application

Application #078321

Application Sponsors

ANDA 078321

CSPC OUYI

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	500MG	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	750MG	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2016-05-12	UNKNOWN

Submissions Property Types

SUPPL

3

Null

7

TE Codes

001	Prescription	AB1
002	Prescription	AB

CDER Filings

CSPC OUYI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78321
            [companyName] => CSPC OUYI
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)