ANDA 211654

MSN LABS PVT LTD

FDA Drug Application

Application #211654

Documents

• Letter: 2020-06-09

Application Sponsors

ANDA 211654

MSN LABS PVT LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE; ORAL

20MG

0

TASIMELTEON

TASIMELTEON

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-05-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

MSN LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211654
            [companyName] => MSN LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TASIMELTEON","activeIngredients":"TASIMELTEON","strength":"20MG","dosageForm":"CAPSULE; 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\\\/211654Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-28
        )

)