ANDA 213825

AIRIS PHARMA PVT LTD

FDA Drug Application

Application #213825

Application Sponsors

ANDA 213825

AIRIS PHARMA PVT LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

0.25GM/ML

0

AMINOCAPROIC ACID

AMINOCAPROIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

AIRIS PHARMA PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213825
            [companyName] => AIRIS PHARMA PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"0.25GM\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-08
        )

)