ANDA 204587

HETERO LABS LTD III

FDA Drug Application

Application #204587

Application Sponsors

ANDA 204587

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

100MG

0

RITONAVIR

RITONAVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-17

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204587
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"RITONAVIR","activeIngredients":"RITONAVIR","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-17
        )

)