ANDA 216635

ALKEM LABS LTD

FDA Drug Application

Application #216635

Application Sponsors

ANDA 216635

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

50MG

0

DICLOFENAC POTASSIUM

DICLOFENAC POTASSIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216635
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC POTASSIUM","activeIngredients":"DICLOFENAC POTASSIUM","strength":"50MG","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/20\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-20
        )

)