SCIEGEN PHARMS INC FDA Approval ANDA 205129

ANDA 205129

SCIEGEN PHARMS INC

FDA Drug Application

Application #205129

Application Sponsors

ANDA 205129SCIEGEN PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL50MG0CELECOXIBCELECOXIB
002CAPSULE;ORAL100MG0CELECOXIBCELECOXIB
003CAPSULE;ORAL200MG0CELECOXIBCELECOXIB
004CAPSULE;ORAL400MG0CELECOXIBCELECOXIB

FDA Submissions

UNKNOWN; ORIG1AP2020-12-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

SCIEGEN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205129
            [companyName] => SCIEGEN PHARMS 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"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-03
        )

)

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