ANDA 212360

CAPLIN

FDA Drug Application

Application #212360

Application Sponsors

ANDA 212360

CAPLIN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

TRANEXAMIC ACID

TRANEXAMIC ACID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-07-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-12-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-06-04	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AP

CDER Filings

CAPLIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212360
            [companyName] => CAPLIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-17
        )

)