ANDA 215017

MSN PHARMS INC

FDA Drug Application

Application #215017

Documents

• Letter: 2022-01-12

Application Sponsors

ANDA 215017

MSN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET; ORAL	5MG	0	OBETICHOLIC ACID	OBETICHOLIC ACID
002	TABLET; ORAL	10MG	0	OBETICHOLIC ACID	OBETICHOLIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-12-15

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215017
            [companyName] => MSN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OBETICHOLIC ACID","activeIngredients":"OBETICHOLIC ACID","strength":"5MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"OBETICHOLIC ACID","activeIngredients":"OBETICHOLIC ACID","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/15\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215017Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-15
        )

)