ANDA 204735

INGENUS PHARMS LLC

FDA Drug Application

Application #204735

Application Sponsors

ANDA 204735

INGENUS PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.5MG

0

CABERGOLINE

CABERGOLINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-08-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204735
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABERGOLINE","activeIngredients":"CABERGOLINE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/01\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-13
        )

)