ANDA 214367

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #214367

Documents

• Letter: 2021-05-07

Application Sponsors

ANDA 214367

MSN LABORATORIES PRIVATE LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006
• None (Tentative Approval): 007
• None (Tentative Approval): 008

Application Products

001	UNKNOWN	UNKNOWN	0	SELEXIPAG	SELEXIPAG
002	TABLET;ORAL	0.4MG	0	SELEXIPAG	SELEXIPAG
003	TABLET;ORAL	0.6MG	0	SELEXIPAG	SELEXIPAG
004	TABLET;ORAL	0.8MG	0	SELEXIPAG	SELEXIPAG
005	TABLET;ORAL	1MG	0	SELEXIPAG	SELEXIPAG
006	TABLET;ORAL	1.2MG	0	SELEXIPAG	SELEXIPAG
007	TABLET;ORAL	1.4MG	0	SELEXIPAG	SELEXIPAG
008	TABLET;ORAL	1.6MG	0	SELEXIPAG	SELEXIPAG

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-04-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABORATORIES PRIVATE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214367
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SELEXIPAG","activeIngredients":"SELEXIPAG","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/07\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-07
        )

)