ANDA 213576

MSN PHARMACEUTICALS INC

FDA Drug Application

Application #213576

Documents

• Letter: 2021-10-08

Application Sponsors

ANDA 213576

MSN PHARMACEUTICALS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	75MG	0	ELUXADOLINE	ELUXADOLINE
002	TABLET;ORAL	100MG	0	ELUXADOLINE	ELUXADOLINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-09-23

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN PHARMACEUTICALS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213576
            [companyName] => MSN PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELUXADOLINE","activeIngredients":"ELUXADOLINE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ELUXADOLINE","activeIngredients":"ELUXADOLINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213576Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-23
        )

)