ANDA 211479

MSN LABS PVT LTD

FDA Drug Application

Application #211479

Documents

• Letter: 2020-06-04

Application Sponsors

ANDA 211479

MSN LABS PVT LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	TABLET, EXTENDED RELEASE; ORAL	5MG; 500MG	0	DAPAGLIFLOZIN	METFORMIN HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE; ORAL	5MG; 1GM	0	DAPAGLIFLOZIN	METFORMIN HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE; ORAL	10MG; 500MG	0	DAPAGLIFLOZIN	METFORMIN HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE; ORAL	10MG; 1GM	0	DAPAGLIFLOZIN	METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-05-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211479
            [companyName] => MSN LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPAGLIFLOZIN","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"5MG; 500MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DAPAGLIFLOZIN","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"5MG; 1GM","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DAPAGLIFLOZIN","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"10MG; 500MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DAPAGLIFLOZIN","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"10MG; 1GM","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/01\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211479Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-01
        )

)