STRIDES PHARMA FDA Approval ANDA 077928

ANDA 077928

STRIDES PHARMA

FDA Drug Application

Application #077928

Application Sponsors

ANDA 077928STRIDES PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL7.5MG0MELOXICAMMELOXICAM
002TABLET;ORAL15MG0MELOXICAMMELOXICAM

FDA Submissions

ORIG1AP2009-05-13
LABELING; LabelingSUPPL3AP2016-10-17STANDARD
LABELING; LabelingSUPPL4AP2016-10-17STANDARD
LABELING; LabelingSUPPL5AP2019-10-23STANDARD
LABELING; LabelingSUPPL6AP2022-01-07STANDARD

Submissions Property Types

SUPPL3Null15
SUPPL4Null15
SUPPL5Null15
SUPPL6Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77928
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELOXICAM","activeIngredients":"MELOXICAM","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MELOXICAM","activeIngredients":"MELOXICAM","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MELOXICAM","submission":"MELOXICAM","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MELOXICAM","submission":"MELOXICAM","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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