ANDA 201580

XGEN PHARMS

FDA Drug Application

Application #201580

Application Sponsors

ANDA 201580

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

TRANEXAMIC ACID

TRANEXAMIC ACID

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2013-06-14
LABELING; Labeling	SUPPL	3	AP	2020-06-25	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-03-19	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AP

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201580
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/19\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/25\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-03-19
        )

)