ANDA 202286

APOTEX INC

FDA Drug Application

Application #202286

Documents

• Review: 2016-07-29

Application Sponsors

ANDA 202286

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

650MG

0

TRANEXAMIC ACID

TRANEXAMIC ACID

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-01-27
LABELING; Labeling	SUPPL	5	AP	2021-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202286
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"650MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2014\\\/202286Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-01-27
        )

)