ANDA 207623

ALKEM LABS LTD

FDA Drug Application

Application #207623

Application Sponsors

ANDA 207623

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

20MG/ML

0

PREGABALIN

PREGABALIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207623
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"20MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-19
        )

)