ANDA 202436

ACIC PHARMS

FDA Drug Application

Application #202436

Application Sponsors

ANDA 202436

ACIC PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

TRANEXAMIC ACID

TRANEXAMIC ACID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-02-11
LABELING; Labeling	SUPPL	3	AP	2019-09-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-10-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ACIC PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202436
            [companyName] => ACIC 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":"02\/11\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/29\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/13\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-29
        )

)