ANDA 212604

INVATECH

FDA Drug Application

Application #212604

Application Sponsors

ANDA 212604

INVATECH

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

20MG/ML

0

PREGABALIN

PREGABALIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

INVATECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212604
            [companyName] => INVATECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"20MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-18
        )

)