APOTEX FDA Approval ANDA 203431

ANDA 203431

APOTEX

FDA Drug Application

Application #203431

Documents

Letter2015-07-15

Application Sponsors

ANDA 203431APOTEX

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.004%0TRAVOPROSTTRAVOPROST

FDA Submissions

UNKNOWN; ORIG1AP2015-07-10
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2020-01-27UNKNOWN
LABELING; LabelingSUPPL10AP2020-09-03STANDARD

Submissions Property Types

ORIG1Null19
SUPPL5Null7
SUPPL10Null15

TE Codes

001PrescriptionAT

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
        )

)

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