ANDA 202093

ACTAVIS LABS FL INC

FDA Drug Application

Application #202093

Documents

• Letter: 2012-05-24
• Letter: 2012-12-28
• Review: 2016-11-02

Application Sponsors

ANDA 202093

ACTAVIS LABS FL 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	2012-12-27
LABELING; Labeling	SUPPL	9	AP	2021-12-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	9	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202093
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"650MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202093Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202093s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202093Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/22\/2021","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-12-22
        )

)