ANDA 203256

ANI PHARMS INC

FDA Drug Application

Application #203256

Application Sponsors

ANDA 203256

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

650MG

0

TRANEXAMIC ACID

TRANEXAMIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-07-25

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ANI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203256
            [companyName] => ANI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"650MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-07-25
        )

)