ANDA 208990

ZYDUS PHARMS

FDA Drug Application

Application #208990

Application Sponsors

ANDA 208990

ZYDUS PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE;300MG

0

ABACAVIR SULFATE AND LAMIVUDINE

ABACAVIR SULFATE; LAMIVUDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208990
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE AND LAMIVUDINE","activeIngredients":"ABACAVIR SULFATE; LAMIVUDINE","strength":"EQ 600MG BASE;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/23\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-23
        )

)