ANDA 215389

MSN LABS PVT LTD

FDA Drug Application

Application #215389

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 215389

MSN LABS PVT LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	600MG	0	DARUNAVIR	DARUNAVIR
002	TABLET;ORAL	800MG	0	DARUNAVIR	DARUNAVIR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-24

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215389
            [companyName] => MSN LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-24
        )

)