ANDA 091596

FRESENIUS KABI USA

FDA Drug Application

Application #091596

Application Sponsors

ANDA 091596

FRESENIUS KABI USA

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	2012-03-02
LABELING; Labeling	SUPPL	2	AP	2016-02-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-08-14	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-06-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91596
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRANEXAMIC ACID","submission":"TRANEXAMIC ACID","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)