ALEMBIC PHARMS LTD FDA Approval ANDA 204519

ANDA 204519

ALEMBIC PHARMS LTD

FDA Drug Application

Application #204519

Application Sponsors

ANDA 204519ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2015-08-21
LABELING; LabelingSUPPL2AP2016-09-16STANDARD
LABELING; LabelingSUPPL5AP2019-09-18STANDARD
LABELING; LabelingSUPPL7AP2019-09-18STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL5Null15
SUPPL7Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204519
            [companyName] => ALEMBIC PHARMS LTD
            [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":"08\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Container\/Carton Labels, 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] => 2019-09-18
        )

)

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