ACIC PHARMS FDA Approval ANDA 212925

ANDA 212925

ACIC PHARMS

FDA Drug Application

Application #212925

Application Sponsors

ANDA 212925ACIC PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL200MG0CELECOXIBCELECOXIB
002CAPSULE;ORAL400MG0CELECOXIBCELECOXIB

FDA Submissions

UNKNOWN; ORIG1AP2020-12-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ACIC PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212925
            [companyName] => ACIC PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-09
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.