ANDA 216843

PAR PHARM

FDA Drug Application

Application #216843

Application Sponsors

ANDA 216843

PAR PHARM

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

12MG

0

ALVIMOPAN

ALVIMOPAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216843
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALVIMOPAN","activeIngredients":"ALVIMOPAN","strength":"12MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/24\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-24
        )

)