ANDA 211533

MSN LABS PVT LTD

FDA Drug Application

Application #211533

Documents

• Letter: 2020-06-09

Application Sponsors

ANDA 211533

MSN LABS PVT LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

10MG/5MG

0

DAPAGLIFLOZIN AND SAXAGLIPTIN

SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE AND DAPAGLIFLOZIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-05-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211533
            [companyName] => MSN LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPAGLIFLOZIN AND SAXAGLIPTIN","activeIngredients":"SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE AND DAPAGLIFLOZIN","strength":"10MG\/5MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/28\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211533Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-28
        )

)