ANDA 208979

ZYDUS PHARMS

FDA Drug Application

Application #208979

Application Sponsors

ANDA 208979

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

ALBENDAZOLE

ALBENDAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208979
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBENDAZOLE","activeIngredients":"ALBENDAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/25\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-25
        )

)