ANDA 203431

APOTEX

FDA Drug Application

Application #203431

Documents

• Letter: 2015-07-15

Application Sponsors

ANDA 203431

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.004%

0

TRAVOPROST

TRAVOPROST

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2020-01-27	UNKNOWN
LABELING; Labeling	SUPPL	10	AP	2020-09-03	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	5	Null	7
SUPPL	10	Null	15

TE Codes

001

Prescription

AT

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203431
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAVOPROST","activeIngredients":"TRAVOPROST","strength":"0.004%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/10\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203431Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/03\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/27\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/27\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-03
        )

)