ANDA 204189

CADILA

FDA Drug Application

Application #204189

Application Sponsors

ANDA 204189

CADILA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

600MG

0

GEMFIBROZIL

GEMFIBROZIL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-08-28

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204189
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMFIBROZIL","activeIngredients":"GEMFIBROZIL","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/10\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-12-10
        )

)