ESKAYEF FDA Approval ANDA 215616

ANDA 215616

ESKAYEF

FDA Drug Application

Application #215616

Application Sponsors

ANDA 215616ESKAYEF

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2.5MG0METOLAZONEMETOLAZONE
002TABLET;ORAL5MG0METOLAZONEMETOLAZONE
003TABLET;ORAL10MG0METOLAZONEMETOLAZONE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ESKAYEF
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215616
            [companyName] => ESKAYEF
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOLAZONE","activeIngredients":"METOLAZONE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOLAZONE","activeIngredients":"METOLAZONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOLAZONE","activeIngredients":"METOLAZONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/24\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-24
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.