ANDA 214822

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #214822

Application Sponsors

ANDA 214822

MSN LABORATORIES PRIVATE LTD

Marketing Status

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-02-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABORATORIES PRIVATE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214822
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"2.5MG\/1000","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"5MG\/1000","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-03
        )

)