ANDA 208459

MSN LABS PVT LTD

FDA Drug Application

Application #208459

Documents

• Letter: 2018-10-15

Application Sponsors

ANDA 208459

MSN LABS PVT LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-09-26

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208459
            [companyName] => MSN LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/26\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208459Orig1s000TALtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-26
        )

)