AACE PHARMS FDA Approval ANDA 216216

ANDA 216216

AACE PHARMS

FDA Drug Application

Application #216216

Application Sponsors

ANDA 216216AACE PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-10-25STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AACE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216216
            [companyName] => AACE PHARMS
            [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\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-25
        )

)

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