ANDA 205096

CSPC OUYI

FDA Drug Application

Application #205096

Documents

• Letter: 2016-07-13

Application Sponsors

ANDA 205096

CSPC OUYI

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

UNKNOWN;	ORIG	1	AP	2016-07-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-06-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-06-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CSPC OUYI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205096
            [companyName] => CSPC OUYI
            [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":"07\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205096Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-07-11
        )

)