APOTEX INC FDA Approval ANDA 204197

ANDA 204197

APOTEX INC

FDA Drug Application

Application #204197

Application Sponsors

ANDA 204197APOTEX INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL50MG0CELECOXIBCELECOXIB
002CAPSULE;ORAL100MG0CELECOXIBCELECOXIB
003CAPSULE;ORAL200MG0CELECOXIBCELECOXIB

FDA Submissions

UNKNOWN; ORIG1AP2015-06-02
LABELING; LabelingSUPPL2AP2016-09-16STANDARD
LABELING; LabelingSUPPL6AP2019-07-25STANDARD
LABELING; LabelingSUPPL7AP2019-10-01STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL6Null7
SUPPL7Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204197
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/02\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/01\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/25\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/16\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/16\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-01
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.