ANDA 206594

AKORN

FDA Drug Application

Application #206594

Application Sponsors

ANDA 206594

AKORN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

TRANEXAMIC ACID

TRANEXAMIC ACID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-09-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-11-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206594
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/14\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-05-14
        )

)