ANDA 091657

MYLAN INSTITUTIONAL

FDA Drug Application

Application #091657

Application Sponsors

ANDA 091657

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

TRANEXAMIC ACID

TRANEXAMIC ACID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2011-11-03
LABELING; Labeling	SUPPL	2	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2018-05-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-06-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	6	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91657
            [companyName] => MYLAN INSTITUTIONAL
            [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
        )

)