ANDA 211478

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #211478

Documents

• Letter: 2021-03-10

Application Sponsors

ANDA 211478

MSN LABORATORIES PRIVATE LTD

Marketing Status

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

Application Products

001	UNKNOWN	UNKNOWN	0	DAPAGLIFLOZIN	DAPAGLIFLOZIN
002	TABLET;ORAL	10MG	0	DAPAGLIFLOZIN	DAPAGLIFLOZIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-02-26

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABORATORIES PRIVATE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211478
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPAGLIFLOZIN","activeIngredients":"DAPAGLIFLOZIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/26\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-26
        )

)